[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-loss":25},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,72,0,25,[9,46,73,101,127,157,182,213,239,259,290,316,337,371,397,422,454,481,501,522,553,573,601,626,683],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100490774","collection-of-clinical-data-and-specimens-for-research-in-hearing-balance-taste-smell-voice-speech-and-language-disorders-100490774",false,"NCT05670496","Collection of Clinical Data and Specimens for Research in Hearing, Balance, Taste, Smell, Voice, Speech, and Language Disorders.","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Patients must be age 2 years or older if procedures or treatment are required.\n* Patients at risk, suspected of having, have a history of, or currently have a diagnosed hearing, balance, taste, smell, voice, speech, language, and other ENT disorder.\n* An NIDCD clinical investigator and PI determines it is in the interest of the patient\u002Findividual and NIDCD CRP for the subject to undergo consult, treatment or follow-up at the NIDCD\u002FNIH\n* Patient or their Legally Authorized Representative is able to provide informed consent. The consent form will be signed by parents or guardians of patients under the age of 18.\n* A subset of enrolled participants with known or suspected PIEZO2-related sensory dysfunction may be asked to participate in the remote taste and oral somatosensory testing procedures. Participation in this component is optional and not required for enrollment or continued participation in the parent protocol.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Candidates who do not meet the inclusion criteria.\n* Candidates who in the opinion of the PI and clinical team have medical or unstable conditions for which NIDCD and CC consultative services are unable to provide or support optimal care\n\nParticipants without known or suspected PIEZO2-related sensory dysfunction will not be asked to complete the sensory testing component. Additional exclusion criteria for taste testing only procedures include:\n\n* Active oral sores, open cuts, or significant oral pain\n* Recent oral surgery or dental procedures within the past 7 days\n* Known allergy or hypersensitivity to tannins or polyphenols\n* Acute upper respiratory infection or conditions that may interfere with taste perception","ALL","2 Years","99 Years",{"count":20,"type":21},600,"ESTIMATED","OBSERVATIONAL","Background:\n\nPeople with hearing, balance, and taste, smell, voice, speech, language, and other Ear, Nose, and Throat (ENT) disorders may seek treatment at the National Institute on Deafness and Other Communication Disorders (NIDCD). Some of these people may benefit from enrolling in the NIDCD intramural research program to receive their care. Enrolling will also allow investigators to collect participants clinical data and specimens for future research.\n\nObjective:\n\nThis natural history study has 2 goals: (1) to collect data and specimens that may be used for research; and (2) to evaluate participants who may be candidates for other research studies.\n\nEligibility:\n\nPeople aged 2 years or older with a hearing, balance, and communication disorder. Those at risk or who are suspected of having such a disorder are also eligible.\n\nDesign:\n\nParticipants will be screened. Their medical records will be reviewed.\n\nParticipants will agree to have their medical data used for research. Specimens such as blood or other tissue samples may also be used for research. All data and specimens will be collected during their routine care visits.\n\nAll tests done will be the normal care for each participant s condition. No tests will be done solely for research.\n\nSome of these tests may require blood or tissue samples. Some may use special tools to test hearing and balance. Some may test heart or lung function. These tests may also include different types of imaging scans.\n\nAll tests will be explained. Participants may ask questions at any time.\n\nParticipants may remain in this study for up to 2 years. If they need further care, they may sign a new consent.\n\n...",[25,26],"Hearing Loss","Deafness",[26,28,29,30,31,32],"Hearing","Speech","Vestibular","Audiology","Natural History","RECRUITING","2026-08-15",{"date":36,"type":37},"2026-08-18","ACTUAL",{"date":39,"type":37},"2023-03-08",{"date":41,"type":21},"2032-12-01",{"name":43,"class":44},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100523798","new-algorithms-to-signal-processing-for-speech-enhancement-in-adult-cochlear-implant-recipients-100523798","NCT06100393","New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.","A Feasibility, Prospective, Repeated-measures Investigation of Hearing Outcomes With New Pre-processing Speech Enhancement Algorithms Compared to Standard-of-care Algorithms in Adult Cochlear Implant Recipients","PRESENCE-MU","Inclusion Criteria:\n\n* User of an approved Nucleus cochlear implant.\n* User of the ACE (Advanced Combination Encoder) sound processing strategy.\n* Aged 18 years or older (no upper age limit).\n* Able to score 20% or more at +10 dB SNR or have an adaptive Speech Recognition Threshold (SRT) of 12 dB or less CI alone on a sentence in babble test.\\*\n* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.\n* Willing and able to provide written informed consent.\n* ≥3 months post cochlear implant activation\n\nExclusion Criteria:\n\n* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.\n* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.\n* Investigator site personnel directly affiliated with this study and\u002For the investigator's immediate families; immediate family is defined as a spouse, parent, child, or sibling.\n* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.\n* Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless the other investigation was\u002Fis a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).","18 Years",{"count":56,"type":21},150,"INTERVENTIONAL",[59],"NA","The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners. The Clinical Investigation will be comprised of several arms which will aim to optimize speech enhancement algorithms, to improve real-world functionality, and to incorporate them efficiently into CI speech processors.",[25],"2026-08-13",{"date":64,"type":37},"2026-08-14",{"date":66,"type":37},"2024-02-22",{"date":68,"type":21},"2026-10-31",{"name":70,"class":71},"Cochlear","INDUSTRY",2,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":16,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":57,"phases":84,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100524755","otc-hearing-aid-and-mci-100524755","NCT06112860","OTC Hearing Aid and MCI","Over-the-counter Hearing Aids and Mild Cognitive Impairment","Inclusion Criteria:\n\n* Over 60 years of age\n* Mild dementia or mild cognitive impairment. Diagnosis will be made at participating memory evaluation centers (see recruitment).\n* Mild to moderate bilateral hearing loss and no current hearing aid use.\n* A communication partner who is able and willing to participate in the study.\n* No vision impairment that would interfere with the ability to complete study tasks (i.e., legally blind, severe cataracts, or macular degeneration)\n* Able to provide own consent as evaluated by the Consent Assessment\n\nExclusion Criteria:\n\n1. Clinically significant unstable or progressive medical conditions, or conditions which, in the opinion of the investigator(s) places the participant at unacceptable risk if he or she were to participate in the study.\n2. History of unresolved communication difficulties following another neurological problem (i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down's syndrome), or head\u002Fneck cancer\n3. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated depression)\n4. Co-enrolled in other intervention studies targeting hearing, language, or communication strategies.\n5. History or current fluctuating hearing loss","60 Years","90 Years",{"count":83,"type":21},50,[59],"The goal of this study is to better understand if, in patients with mild to moderate hearing loss who are also experiencing mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD), Over-the-Counter (OTC) hearing aids:\n\n1. improve communication\n2. Whether the magnitude of benefit depends on the patient's level of cognitive disability,\n3. Whether alternative remediation (such as targeted communication strategies) offer similar benefits.\n\nParticipants and a communication partner will be randomized into an OTC first or Communication Strategies first arm, where participants will receive communication strategy information customized for those with cognitive impairment.",[25,87,88],"Mild Cognitive Impairment","Alzheimer Disease and Related Dementias (ADRD)",[90],"Over-the-counter Hearing Aids","2026-08-12",{"date":64,"type":37},{"date":94,"type":37},"2024-07-23",{"date":96,"type":21},"2027-03-30",{"name":98,"class":99},"Northwestern University","OTHER",3,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":16,"minAge":54,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":57,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":45},"100555783","listening-effort-in-cochlear-implant-users-100555783","NCT06516575","Listening Effort in Cochlear Implant Users","Inclusion Criteria:\n\nTo be eligible for this study, a participant must:\n\n* Be an adult between the age of 18 to 75 years\n* Have had normal hearing and speech\u002Flanguage development as a young child\n* For younger NH listeners: have normal audiometric thresholds below 25 dB HL at frequencies between 250 and 8000 Hz\n* for cochlear implant listeners: at least 6 months experience with a cochlear implant\n* For older (55+ years) age-matched listeners with no cochlear implant: normal audiometric thresholds below 25 dB HL at frequencies between 250 and 2000 Hz and thresholds below 35 dB HL (hearing level) between 4000 and 8000 Hz\n* For cochlear implant listeners: be able to recognize spoken words in English at a rate of at least 50%\n* Be a competent speaker of north American English\n* Lack language-learning or other cognitive disabilities\n* Lack of auditory neuropathy spectrum disorder\n\nExclusion Criteria:\n\n* unable to fix gaze position\n* eye disease preventing typical changes in pupil dilation\n* lack of perceptual and productive fluency in English",true,"75 Years",{"count":110,"type":21},450,[59],"People with hearing loss experience extra effort when listening, which can lead to severe psychological barriers to communication and social participation. Listening effort can lead to fatigue, mental strain, burnout, medical sick leave, and the need for increased time to recover from regular daily activities. This proposal aims to understand effort changes on a moment-to-moment basis during listening, how long the effort lasts, and how the planning and execution of effort is impacted by the experience of using a cochlear implant.",[114,115,25],"Auditory Perception; Abnormal","Hearing Loss, Sensorineural",[117,118],"cochlear implants","listening effort","2026-08-10",{"date":62,"type":37},{"date":122,"type":37},"2023-09-01",{"date":124,"type":21},"2028-08-31",{"name":126,"class":99},"University of Minnesota",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":16,"minAge":135,"maxAge":108,"enrollmentInfo":136,"targetDuration":4,"studyType":57,"phases":137,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":45},"100529458","early-age-related-hearing-loss-investigation-earhli-100529458","NCT06174038","Early Age-Related Hearing Loss Investigation (EARHLI)","Early Age-Related Hearing Loss Investigation (EARHLI): A Randomized Controlled Trial to Assess the Mechanisms Linking Early Age-Related Hearing Loss and Alzheimer's Disease and Related Dementias","EARHLI","Inclusion Criteria:\n\n* Age 55-75 years of age\n* Adult-onset hearing loss of approximately mild to moderate in severity (4-frequency 0.5, 1, 2, 4 kHz pure tone average 20 dB to 55 dB HL in better hearing ear)\n* Aidable hearing loss, defined by word recognition score in quiet ≥ 60% in better hearing ear\n* Amnestic mild cognitive impairment (MCI) defined by Mini-Mental State Exam (MMSE2) score \\>23, Clinical Dementia Rating (CDR) global score equivalent = 0.5, and ADNI3 criteria of Logical Memory II score of ≤6 if 0-7 years of education, ≤9 if 8-15 years, and ≤11 if ≥16 years\n* Availability of a study partner (informant) for the administration of the cognitive screen and the ADCS-Activities of Daily Living-Prevention Instrument (ADCS-ADL-PI)\n* Community-dwelling\n* Fluent in English or Spanish\n* Availability of participant in area for study duration\n\nExclusion Criteria:\n\n* Self-reported congenital hearing loss, known genetic mutation-related hearing loss, or hearing loss onset before middle age (\\\u003C45 years old)\n* Prior dementia diagnosis\n* Reported disability in ≥ 2 activities of daily living (ADLs)\n* Current or previous consistent hearing aid user (such as utilization of hearing aids within the past 6 months beyond brief trials)\n* Unwillingness to wear hearing aids regularly (≥8 hours\u002Fday)\n* Medical contraindications to the use of hearing aids (e.g., actively draining ear)\n* Corrected vision impairment (worse than 20\u002F63 on MNRead Acuity Chart in worse eye)\n* Untreatable conductive hearing loss with air-bone gap \\> 15 dB in two or more contiguous octave frequencies in both ears","55 Years",{"count":56,"type":21},[59],"Early Age-Related Hearing Loss Investigation (EARHLI) is a single site study that will randomize late middle age adults to either a hearing intervention (including hearing aids) or a health education intervention. Participants will be followed for 1 year. This study will provide information on reducing cognitive decline in those at risk for Alzheimer's Disease and Alzheimer's Disease Related Dementias (AD\u002FADRD).",[140,25,141],"Alzheimer Disease","Cognitive Impairment",[25,143,144,145,146,147,148,149],"Alzheimer's","Alzheimer","Hearing Aid","Memory Loss","Memory","Audiogram","Cognition",{"date":91,"type":37},{"date":152,"type":37},"2024-08-01",{"date":154,"type":21},"2027-12-31",{"name":156,"class":99},"Columbia University",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":107,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":57,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100645897","hears-maryland-extending-capacity-for-affordable-accessible-hearing-care-through-older-adult-peer-mentorship-100645897","NCT07699146","HEARS Maryland: Extending Capacity for Affordable, Accessible Hearing Care Through Older Adult Peer Mentorship","HEARS MD","Inclusion Criteria:\n\n* Age 60 years or older\n* English-speaking\n* Aural-oral verbal communication as primary communication modality\n* Post-lingual hearing loss (Audiometric pure tone averages \\[0.5-2kHz\\] in better ear \\>25 dB)\n\nExclusion Criteria:\n\n* Current self-reported use of hearing aid or amplification device\n* Medical contraindication to use hearing aids (e.g. draining ears)",{"count":165,"type":21},300,[59],"This study aims to assess the effectiveness of a Community Health Worker (CHW) delivered hearing loss intervention program (HEARS) for older adults in Maryland in collaboration with community organizations.",[25,169,170,171],"Hearing Impairment","Age Related Hearing Loss","Age-related Hearing Impairment","NOT_YET_RECRUITING","2026-07-28",{"date":175,"type":37},"2026-07-29",{"date":177,"type":21},"2026-11-30",{"date":179,"type":21},"2029-06-30",{"name":181,"class":99},"Johns Hopkins University",{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":16,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":194,"studyType":22,"phases":4,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":72},"100648601","from-early-music-audiometry-to-tone-audiograms-100648601","NCT07722936","From Early Music Audiometry to Tone Audiograms","Understanding the Role of Band-pass Filtered Familiar Music Stimuli for Use in the Assessment of Hearing","FERMATA","Inclusion Criteria:\n\n* Aged 7 to 45 years old\n* Able to reliably perform conventional Pure Tone Audiometry\n* Confirmed stable bilateral hearing loss with a 4-frequency (500, 1000, 2000, 4000 Hz) pure-tone average ≥25 dB HL in the better hearing ear\n\nExclusion Criteria:\n\n* Aged under 7 or over 45 years old\n* Unable to complete reliable conventional audiometry task mechanics\n* Satisfactory hearing or purely unilateral hearing loss (4-frequency pure-tone average in better ear \\\u003C25 dB HL)\n* Fluctuating or unconfirmed hearing threshold variations\n* History of Auditory Processing Disorder (APD)\n* History of Auditory Neuropathy Spectrum Disorder (ANSD)","7 Years","45 Years",{"count":193,"type":21},100,"1 Day","Hearing tests are crucial for a child's development, but the standard test, Visual Reinforcement Audiometry (VRA), often doesn't work for those with social communication disorders (SCD) and autism spectrum disorder (ASD). A standardised filtering tool has been developed. Understanding how the results from this new music test compare to standard test results, particularly in people with hearing loss, is critical to establishing the fundamental psychoacoustic threshold relationship. This basic science research validates the acoustic methodology before any future clinical diagnostic application can be considered",[25,197],"Audiometric Tests",[199,200,201,202,203],"Music Audiometry","Psychoacoustics","Visual Reinforcement Audiometry","Band-Pass Filtered Stimuli","Paediatric Audiology","2026-07-23",{"date":206,"type":37},"2026-07-24",{"date":208,"type":21},"2027-03",{"date":210,"type":21},"2028-05",{"name":212,"class":99},"Guy's and St Thomas' NHS Foundation Trust",{"id":214,"slug":215,"hasResults":12,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":57,"phases":222,"briefSummary":223,"conditions":224,"keywords":227,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":45},"100544929","investigation-of-a-device-to-deliver-intra-operative-therapeutic-hypothermia-for-hearing-preservation-in-cochlear-implantation-100544929","NCT06375278","Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation","Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation","Inclusion Criteria:\n\nPotential participants for the study are patients who have been diagnosed with severe to profound hearing loss (HL) and plan to undergo cochlear implantation (CI) at the University of Miami. The cochlear implant surgery, pre and post-surgical care, and activation and programming of the implant are part of the participants' standard of care. If the inclusion criteria are met (age 18 years and older, equal number of men and women, profound sensorineural hearing loss (for safety study n=6) and residual hearing (see criteria below) from pre-surgical auditory brainstem response (ABR) (for efficacy study n=48), equal numbers of CI devices from all 3 manufactures and English or Spanish speakers the patient will be approached by the study personnel and will be asked to participate in the study.\n\nExclusion Criteria:\n\nSubjects under 18 years of age. Subjects not meeting functional hearing requirements.\n\nTypes of CI devices:\n\nThe study will enroll patients receiving CI devices from all three manufactures.\n\n1. Advanced Bionics (FDA indications - severe to profound sensorineural hearing loss (greater than or equal to 70 dB HL)\n\n   1. HiRes Ultra 3D slim J\n   2. HiRes Ultra 3D midScala\n2. Cochlear Corporation (FDA indications - moderate to profound sensorineural hearing loss; sentence recognition less than or equal to 50% in the ear to be implanted AND less than or equal to 60% in the contralateral ear\n\n   1. CI632\n   2. CI622\n   3. CI612\n3. Med-EL (moderately-severe to severe sensorineural hearing loss (greater than or equal to 65 db HL).\n\n   1. Synchrony 2 Flex soft\n   2. Synchrony 2 Flex28\n   3. Synchrony 2 Flex 24\n   4. Synchrony 2 Compressed\n   5. Synchrony 2 Medium\n\nAdditional patients receiving devices not listed here may be eligible as the criteria by manufacturer change.",{"count":221,"type":21},54,[59],"The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are:\n\n1. Is mild therapeutic hypothermia safe for use during cochlear implantation?\n2. Is mild therapeutic hypothermia effective at preserving residual hearing after cochlear implantation?\n\nParticipants will receive mild therapeutic hypothermia therapy during cochlear implant surgery. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy).",[225,226,25],"Cochlear Implants","Cochlear Implantation",[228,229,230],"Cochlear Implant","Residual Hearing","Hearing Preservation","2026-07-22",{"date":204,"type":37},{"date":234,"type":37},"2024-09-23",{"date":236,"type":21},"2027-09-30",{"name":238,"class":71},"Restorear Devices LLC",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":107,"sex":16,"minAge":245,"maxAge":18,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":45},"100400964","natural-history-of-autosomal-dominant-hearing-loss-100400964","NCT04501081","Natural History of Autosomal Dominant Hearing Loss","* INCLUSION CRITERIA:\n* Affected persons with autosomal dominant hereditary sensorineural hearing loss, preferably confirmed by prior genetic testing\n* Affected family members of enrolled participants with known autosomal dominant hereditary hearing loss\n* Unaffected Family Members (Healthy Volunteers) of enrolled participant\n* Adults must be able to provide informed consent\n* Minors must have a parent or guardian able to provide informed consent\n* Subjects must be 3-99 years of age\n\nEXCLUSION CRITERIA:\n\n* Persons with sensorineural hearing loss (SNHL) and\u002For peripheral vestibular dysfunction associated with a non-genetic etiology such as infection, metabolic or immunologic disorders, or exposure to ototoxic agents such as cisplatin, or aminoglycoside antibiotics will not be included in this protocol.\n* Persons with sensorineural hearing loss known to be associated with surgical intervention (e.g. acoustic neuroma removal, failed stapedectomy).\n\nProspective study subjects who are cognitively impaired and lack consent capacity, will not be enrolled. The pre-screening eligibility checklist, which will be used and documented for registration under this protocol, is provided in a separate document.","3 Years",{"count":247,"type":21},1100,"Background:\n\nHereditary hearing loss is one of the most common sensory disabilities affecting newborns. The main options for people with hereditary hearing loss are hearing aids and cochlear implants. Both options have their limitations and do not restore biological hearing. Researchers want to learn if gene editing might be a treatment option.\n\nObjective:\n\nTo understand the genes that cause non-syndromic autosomal dominant hearing loss (DFNA) in people with DFNA as well as their family members.\n\nEligibility:\n\nPeople age 3 99 who have DFNA, affected family members of enrolled participants with DFNA, and unaffected family members of enrolled participants\n\nDesign:\n\nParticipants will be screened with a medical and hearing history. Their medical records will be reviewed.\n\nParticipants will have hearing tests. They will wear headphones or earplugs. They will listen to tones, sounds, and words and may be asked to describe what they hear.\n\nParticipants will have balance tests. For these, they will wear googles as they watch moving lights or as cold or warm air is blown into their ears. They will sit in a spinning chair in a quiet, dark booth. From a reclined position, they will raise their head while listening to clicking sounds.\n\nParticipants will have blood drawn through a needle in the arm. Some blood will be used for gene testing.\n\nSome participants will have 2 skin biopsies. The skin will be washed, and a numbing medicine will be injected. Two small pieces of skin will be removed.\n\nParticipants may have a physical exam.\n\nParticipation will last for up to 20 years. Participants may give medical updates once a year.",[25],[251,252,32],"DFNA","Genome Editing",{"date":204,"type":37},{"date":255,"type":37},"2021-02-09",{"date":257,"type":21},"2029-08-21",{"name":43,"class":44},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":57,"phases":268,"briefSummary":269,"conditions":270,"keywords":271,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":72},"100646494","whatsapp-ai-support-vs-paper-support-for-first-time-hearing-aid-users-100646494","NCT07690670","WhatsApp AI Support vs Paper Support for First-Time Hearing Aid Users","A WhatsApp-Delivered AI-Enabled Support Programme Versus Paper-Based Support for First-Time Hearing Aid Users in Low-Resource Communities: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 18 years and older\n* Confirmed mild to severe (20 to \\\u003C 80 dB PTA in both ears) hearing loss (determined during baseline assessments)\n* Willing\u002Favailable to commit to 5-week follow-up\n* Must have access to their own personal WhatsApp\n* Functional proficiency in English, isiXhosa, or Sepedi sufficient to provide informed consent and to self-complete the study outcome measures in one of these three languages, as judged by the recruiting CHW during the screening conversation.\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Hearing loss too severe (≥80 dB HL PTA)\n* Normal hearing (\\\u003C20 dB HL PTA)\n* Middle ear pathology, such as otitis media, active drainage from the ears.\n* Unwilling\u002Funavailable to commit to a 5-week follow-up.\n* Unilateral hearing loss\n* No access to WhatsApp\u002Fonly has access via another individual's WhatsApp\n* Home language other than English, isiXhosa, or Sepedi, where the individual does not have functional proficiency in any of these three languages.",{"count":267,"type":21},66,[59],"The purpose of this study is to advance hearing care in low- and middle-income countries (LMICs) through the rigorous evaluation and optimization of innovative interventions and technologies. This study encompasses the following key aim:\n\nThis study aims to evaluate the effectiveness of a WhatsApp-delivered AI-enabled support and acclimatization programme for adults receiving preset hearing aids in low-resource community settings. The AI-enabled programme combines two complementary components delivered through the same WhatsApp channel: (i) a structured push programme of 16 voice notes and images delivered over four weeks, and (ii) an on-demand artificial-intelligence (AI) conversational support agent available throughout the four-week intervention period. The primary objective is to determine whether this WhatsApp-delivered AI-enabled programme results in superior hearing aid self-efficacy compared to receiving the equivalent core information in a paper-based pamphlet at the time of fitting. By comparing hearing aid self-efficacy, hearing aid outcomes, and user engagement between the intervention (WhatsApp AI-enabled) and control (paper-based) groups, this study seeks to establish whether AI-enabled digital delivery provides superior support and leads to better self-efficacy for first-time hearing aid users compared to traditional paper-based methods.",[25],[272,273,274,275,276,277,278,279,280,281],"hearing loss","community-based","hearing aid","service delivery model","community health workers","pre-set hearing aids","randomized controlled trial","mHealth","mHealth acclimatization","low- and middle-income","2026-07-21",{"date":204,"type":37},{"date":285,"type":21},"2026-07-06",{"date":287,"type":21},"2026-12-15",{"name":289,"class":99},"University of Pretoria",{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":16,"minAge":135,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":57,"phases":300,"briefSummary":301,"conditions":302,"keywords":303,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":45},"100648306","benefit-of-a-clinically-streamlined-and-structured-aural-rehabilitation-cssar-program-in-adults-100648306","NCT07719114","Benefit of a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) Program in Adults","Evaluating the Benefits of Aural Rehabilitation for Adult Users of Entry-Level Hearing Aids","CSSAR","Inclusion Criteria:\n\n* Age 55 and over\n* Bilateral, symmetric sensorineural hearing loss\n* New users of binaural entry-level Phonak Receiver-in-Canal hearing aids (for experimental control)\n* Proficiency in English (in order to understand consent documents, experimental English speech recognition tests, and clinically streamlined and structured aural rehabilitation (CSSAR) trainings)\n\nExclusion Criteria:\n\n* Score \\\u003C 23 on cognitive screener\n* Unilateral or asymmetric sensorineural hearing loss\n* Conductive or mixed hearing loss\n* Experienced hearing aid users or users of advanced level hearing aids\n* Less than proficient English speaker",{"count":299,"type":21},60,[59],"The goal of this mixed methods clinical trial is to determine whether a Clinically Streamlined and Structured Aural Rehabilitation (CSSAR) intervention improves hearing aid outcomes for new adult users, age 55 years and older, of entry-level hearing aid technology compared with adults who receive standard audiological care.\n\nThe main questions are:\n\n1. Does the CSSAR intervention result in greater hearing aid benefit, improved aided speech-in-noise performance, and reduced self-perceived hearing handicap among adult users of entry-level hearing aids compared with those who receive standard care, such as a hearing aid evaluation, fitting, and orientation, without a structured aural rehabilitation program?\n2. How do new adult users of entry-level hearing aids perceive audiological care practices with and without the CSSAR intervention?\n\nParticipants will be asked to complete four to five sessions. These sessions may include baseline testing, participation in the CSSAR intervention, two follow-up sessions, and a focus group. For participants in the intervention group, the CSSAR intervention will include a training session with a primary communication partner, followed by use of a mobile auditory training program.",[25],[304,305,306,307],"hearing aids","aural rehabilitation","adults","hard of hearing","2026-07-17",{"date":231,"type":37},{"date":311,"type":21},"2026-09",{"date":313,"type":21},"2028-12",{"name":315,"class":99},"Case Western Reserve University",{"id":317,"slug":318,"hasResults":12,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":336},"100587622","evaluation-of-clinical-outcomes-of-ponto-procedures-performed-in-settings-outside-the-main-operating-room-ie-out-of-or-100587622","NCT06930781","Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)","Inclusion Criteria:\n\n* Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards\n* Signed informed consent (applicable for subjects answering questionnaires)\n\nExclusion Criteria:\n\n* No exclusion criteria have been set for this observational investigation",{"count":323,"type":21},270,"This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.",[25,326],"Bone Anchored Hearing Aids","2026-07-07",{"date":329,"type":37},"2026-07-08",{"date":331,"type":37},"2025-05-07",{"date":333,"type":21},"2027-04-01",{"name":335,"class":71},"Oticon Medical",6,{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":107,"sex":16,"minAge":344,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":347,"conditions":348,"keywords":353,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":367,"leadSponsor":369,"locationsCount":45},"100646171","survey-of-sensory-impairment-indicators-among-adults-aged-65-years-and-older-in-xinxing-county-100646171","NCT07694505","Survey of Sensory Impairment Indicators Among Adults Aged 65 Years and Older in Xinxing County","A Cross-Sectional Survey of Global Priority Sensory Impairment Indicators Among People Aged 65 Years and Older in Xinxing County","Inclusion Criteria:\n\n1. Aged 65 years or older.\n2. Voluntarily participates in the study and provides signed informed consent.\n\nExclusion Criteria:\n\n1. Unable to cooperate with study-related examinations, including because of disability, communication barriers, or other reasons.\n2. Has severe systemic disease that may affect study examinations or make participation potentially hazardous to health.\n3. Considered by the investigator to be unsuitable for participation in the study.","65 Years",{"count":346,"type":21},2854,"This cross-sectional population-based survey will be conducted among residents aged 65 years and older in Xinxing County, Yunfu, Guangdong Province, China. The study will use standardized eye examinations, visual acuity and refractive assessment, anterior segment examination, hearing screening and questionnaires to estimate effective refractive error coverage, effective cataract surgical coverage, effective hearing technology coverage, common eye disease status, and dual sensory impairment among older adults. The findings are intended to provide evidence for primary-level eye and hearing health services.",[349,25,350,351,352],"Visual Impairment","Dual Sensory Impairment","Cataract","Refractive Error",[354,355,356,357,358,359,360,361,362],"Effective refractive error coverage","Effective cataract surgical coverage","Effective hearing technology coverage","Older adults","Population-based survey","Cross-sectional study","SENSIIS","WHOears","Xinxing County","2026-07-02",{"date":365,"type":37},"2026-07-10",{"date":285,"type":21},{"date":368,"type":21},"2026-12-31",{"name":370,"class":99},"Zhongshan Ophthalmic Center, Sun Yat-sen University",{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":57,"phases":380,"briefSummary":381,"conditions":382,"keywords":383,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":45},"100645268","same-day-cochlear-implant-activation-sda-ci-100645268","NCT07681830","Same-Day Cochlear Implant Activation (SDA-CI)","Randomized Study of Same-Day Activation Versus Day-14 Activa- Tion in Adult Cochlear Implant Recipients","SDA-CI","Inclusion Criteria:\n\n* Age 18 years or older\n* Indication for cochlear implantation according to national guidelines\n* Ability to provide written informed consent\n\nExclusion Criteria: - Medical or surgical conditions rendering SDA unsuitable, including postoperative wound complications requiring pressure dressing, cognitive or communicative barriers precluding safe activation, or other clinical considerations (e.g. meningitis) assessed by the treating clinician.\n\n\\-",{"count":193,"type":21},[59],"This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery.\n\nAdult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day activation or standard activation. The study will evaluate electrode impedance development, time to a stable cochlear implant map, changes in programming parameters, hearing outcomes, tinnitus, quality of life, rehabilitation progress, and safety.\n\nThe purpose of the study is to determine whether earlier activation can facilitate faster auditory rehabilitation and optimization of cochlear implant settings without increasing complications or patient discomfort.",[25,226],[228,384,385,386,387,388],"Same-Day Activation","Early Activation","Electrode Impedance","Stable Cochlear Implant Map","Cochlear Implant Mapping","2026-06-30",{"date":363,"type":37},{"date":392,"type":21},"2026-06-01",{"date":394,"type":21},"2029-12-01",{"name":396,"class":99},"University of Aarhus",{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":57,"phases":406,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":420,"locationsCount":336},"100542266","phase-2-spi-1005-in-adults-receiving-cochlear-implant-100542266","NCT06340633","SPI-1005 in Adults Receiving Cochlear Implant","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Adults Receiving a Cochlear Implant","Inclusion Criteria:\n\n* Adults who are ≥18 years of age at time of consent.\n* Post-lingual, bilateral, moderate to profound sensorineural hearing loss scheduled to receive a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.\n* Air conduction thresholds (decibel hearing loss, dB HL) at baseline in the ear scheduled to receive the cochlear implant:\n\n  * ≤70 dB HL at 125, 250, and 500 Hz; AND\n  * ≥70 dB HL at 2000, 4000, and 8000 Hz.\n* Type A (including As and Ad) tympanogram at baseline in the ear scheduled to receive the cochlear implant.\n* Willing and able to provide informed consent and to perform all behavioral tests as specified per-protocol, including pre-specified reproductive requirements.\n\nExclusion Criteria:\n\n* Current, or within 60 days prior to study consent, use of IV ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.\n* Participation in another investigational drug or device study within 90 days prior to study consent.\n* Female patients who are pregnant or breastfeeding.\n* Moderate or severe hepatic impairment using Child-Pugh Score (\\>6 points).\n* No measurable air conduction response at three or more consecutive test frequencies (e.g., 2000, 4000 and 8000 Hz) at baseline in the ear scheduled to receive the cochlear implant.\n* No middle ear mobility (Type B tympanogram) or abnormal middle ear pressure (exceeds -150 to +50 range).",{"count":405,"type":21},40,[407],"PHASE2","The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.\n\nThe main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and\u002For what medical problems might participants experience when taking drug SPI-1005?\n\nThe clinical trial will also measure the effects of SPI-1005 on hearing, word recognition, speech discrimination, tinnitus, and vertigo outcomes after receiving a cochlear implant. The purpose for this and future clinical trials is to learn whether SPI-1005 can prevent or treat these side effects after receiving a cochlear implant.\n\nParticipants will take drug SPI-1005 or placebo (a look-alike substance that contains no drug) for 6 months, starting 2 days before receiving the cochlear implant. There are 5 required in-clinic visits over 6 months for audiology and other tests.\n\nThe effects of SPI-1005 will be compared to the placebo (the look-alike substance that contains no drug) to study what effects SPI-1005 might have.",[25,410],"Cochlear Trauma",[230,228,412,413],"SPI-1005","Ebselen","2026-06-23",{"date":416,"type":37},"2026-06-26",{"date":418,"type":21},"2026-12",{"date":418,"type":21},{"name":421,"class":71},"Sound Pharmaceuticals, Incorporated",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":107,"sex":16,"minAge":430,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":57,"phases":433,"briefSummary":434,"conditions":435,"keywords":441,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":45},"100498831","cochlear-implants-in-young-children-with-ssd-100498831","NCT05775367","Cochlear Implants in Young Children With SSD","Cochlear Implantation in Infants and Toddlers With Single-Sided Deafness","Little SSD","To be eligible to participate in this trial as a study subject, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Unilateral severe-to-profound sensorineural hearing loss, congenital or acquired prior to the age of 2 years, defined as:\n\n   1. Unaided residual hearing thresholds that yield a 3 frequency pure tone average (PTA; average at 500, 1000, and 2000 Hz) of ≥70 dB hearing loss (HL) in the ear to be implanted\n   2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).\n\n   i. Thresholds should be measured using inserts wherever possible, or in the sound field to record the better-hearing ear alone. Required thresholds will include 250, 500, 1000, 2000, and 4000 Hz for air conduction. All other octave frequencies should be attempted. Bone conduction thresholds should be obtained at 500, 1000, 2000, and 4000 Hz. Masking should be attempted where appropriate. As participants are very young and masking is difficult for this population, suspected shadow audiograms will be sufficient if objective testing has confirmed a severe-to-profound unilateral hearing loss. Testing should confirm a severe-to-profound hearing loss, defined as a 3-frequency PTA (500, 1000, and 2000) \\>70 dB HL in one ear and ≤20 dB HL in the contralateral ear. The Primary Investigator and Lead Diagnostic Audiologist must agree on this diagnosis for enrollment.\n3. Insufficient functional access to sound with appropriately fit amplification and aural habilitation (based on best practices and standard of care) defined as:\n\n   1. PEACH + parent questionnaire scores below the expected value for children who lack the requisite language to complete open-set word recognition testing or\n   2. Recorded Multisyllabic Lexical Neighborhood Test (MLNT) scores ≤ 30% in the ear to be implanted for children with the requisite language to complete open-set word recognition testing.\n4. Between 7 months and 2 years, 11 months of age at implantation\n5. Normal cochlear nerve as evaluated by imaging, required imaging by MRI brain\u002FInternal auditory canal (IAC) without contrast with heavily weighted T2 images. CT optional at the physician's discretion.\n6. No malformation of the cochlea\n7. No evidence of progressive hearing loss of the contralateral ear\n8. Willing to\u002Fhas undergone hearing aid trial as warranted based on achieving an aided speech intelligibility index (SII) of \\> .65 when fitted via Desired Sensation Level (DSL) methods.\n9. Realistic parental expectations: a verbal acknowledgment of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing\n10. Willing to obtain recommended meningitis vaccinations per Centers for Disease Control (CDC) recommendations\n11. Development and cognition within the normal range as measured by the Developmental Assessment of Young Children (DAYC-2).\n12. Parental commitment to study parameters including being able and willing to participate in the evaluation schedule, involvement in prescribed therapy, and travel to the investigational site and study-related activities. Parents must be willing to encourage wearing implant during waking hours.\n\nTo participate as an SSD control subject, an individual must meet all the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Unilateral severe-to-profound hearing loss - congenital or acquired prior to 2 years of age.\n\n   1. Unaided residual hearing thresholds that yield a 3 frequency PTA (500, 1000, and 2000 Hz) of ≥70 dB HL in the affected ear.\n   2. Hearing thresholds in the contralateral ear of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz)\n   3. Unable to use or benefit from traditional amplification\n3. Five years of age at the time of testing\n4. Development and cognition within the normal range as measured by the Early Stanford Binet 2 (SB2).\n\nTo participate as a TH control subject, an individual must meet all the following criteria:\n\n1. Provision of signed and dated parental permission form\n2. Bilateral hearing thresholds that yield a PTA of ≤20 dB HL (3 frequency PTA of 500, 1000, and 2000 Hz).\n3. Five years of age at the time of testing\n4. Development and cognition within the normal range as measured by the Early SB2.\n\nAn individual who meets any of the following criteria will be excluded from participation in this study as a study subject:\n\n1. English is not primary language of the home\n\n   1. Speech perception materials are presented in English\n   2. Parental questionnaires are administered in English\n2. Conductive hearing loss in either ear\n3. Cochlear nerve deficiency\n4. Ossification\u002FFibrosis of the cochlea precluding implantation\n5. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)\n6. History of refractory chronic otitis media or condition that contraindicates anesthesia\n\nAn individual who meets any of the following criteria will be excluded from participation in this study as a control subject:\n\n1. English is not primary language of the home\n\n   1. Speech perception materials are presented in English\n   2. Parental questionnaires are administered in English\n2. Inability to participate in testing (i.e., unwillingness)","7 Months","71 Months",{"count":299,"type":21},[59],"The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness.\n\nThe main questions it aims to answer are:\n\n* Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers?\n* Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers?\n\nParticipants will receive a cochlear implant and be followed until they are five years old. During those five years, the investigators will program the device and monitor auditory development.\n\nChildren will be asked to:\n\n* Undergo cochlear implantation\n* Wear their cochlear implant processor whenever they are awake.\n* Participate in traditional hearing tests\n* Participate in traditional hearing testing\n* Participate in localization testing\n* Participate in hearing in noise testing\n* Participate in word recognition testing\n* Participate in speech, language, and educational evaluations\n\nThe researchers will compare results to children with typical hearing in both ears and children with single-sided deafness who have not received an implant to observe any differences between the groups.",[436,437,438,25,439,440],"Single Sided Deafness","Unilateral Deafness","Hearing Loss, Unilateral","Congenital Hearing Loss","Deafness One Ear",[442,443,444,445,272,446],"cochlear implant","uhl","ssd","children","deafness",{"date":416,"type":37},{"date":449,"type":37},"2023-07-07",{"date":451,"type":21},"2030-05-30",{"name":453,"class":99},"University of North Carolina, Chapel Hill",{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":461,"enrollmentInfo":462,"targetDuration":4,"studyType":57,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":480},"100432751","phase-2-atorvastatin-to-reduce-cisplatin-induced-hearing-loss-among-individuals-with-head-and-neck-cancer-100432751","NCT04915183","Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer","Phase II Interventional Study Using Atorvastatin to Reduce Cisplatin-Induced Hearing Loss Among Individuals With Head and Neck Cancer","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria evaluated by the study team, including an on-site oncologist:\n\n* Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study\n* Ability to provide consent and provision of signed and dated informed consent form\n* Adult subjects, aged \\>=18\n* Diagnosed with squamous cell carcinoma of the head and neck, confirmed by a pathologic review of surgical or biopsy specimen(s), who meet standard clinical and laboratory criteria and will undergo treatment with concomitant cisplatin-based chemotherapy and radiation with curative intent or treatment with neoadjuvant chemotherapy (NAC). This includes subjects who will be treated with either intensity-modulated radiation therapy (IMRT) or proton radiotherapy, with planned dose to the cochlea \\\u003C35 Gy (to limit confounding effects of radiation64-67). Patients receiving immunotherapy in addition to cisplatin chemoradiation are eligible. Subjects treated with either high-dose cisplatin (typically 100 mg\u002Fm\\^2 x 2-3 doses every three weeks) or low-dose, weekly cisplatin (typically 40 mg\u002Fm\\^2 x 6-7 doses weekly) may enroll. Cisplatin in the neo-adjuvant setting may be given within a combination chemotherapy regimen (e.g TPF= Docetaxel, Cisplatin and 5FU or DC = Docetaxel Cisplatin)\n* Subjects must have hearing thresholds at or better than 70 dB HL at 1, 2, and 4 kHz in at least one ear at the time of their baseline audiogram. CTCAE criteria (primary endpoint) and ASHA criteria (secondary endpoint) are based on changes in hearing in at\n\nleast one ear with one ototoxicity event\u002Fgrade assigned per person.\n\n* Baseline laboratory tests with lab values \\\u003C1.5x the upper limit of normal: aspartate aminotransferase (AST or SGOT); alanine aminotransferase; creatine phosphokinase, creatinine\n* Ability to take oral medication by mouth or by feeding tube and willingness to adhere to the daily atorvastatin or placebo regimen\n* For females of reproductive potential: use of highly effective contraception for at least 1 month prior to enrollment and agreement to use such a method during study participation and for an additional 8 weeks after the end of atorvastatin administration\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Subjects currently taking a statin drug\n* Subjects with bilateral flat, Type B tympanogram\n* Subjects with bilateral cochlear implants\n* Pre-existing liver or kidney disease that in the opinion of the investigator would interfere with taking Atorvastatin 40 mg daily.\n* Subjects with a history of prior treatment with cisplatin chemotherapy\n* Staff members of the NIDCD Sections and of the lead site investigators headed by the PIs\n* Children will be excluded because HNSCC in children under age 18 is exceedingly rare\n* Current use of cimetidine, spironolactone, ketoconazole, cyclosporine, protease inhibitors, gemfibrozil, clarithromycin or itraconazole\n* Pregnancy, lactation, or plan to become pregnant\n* Known allergic reactions to components of atorvastatin or the placebo\n* Other severe or unstable medical conditions which clinical site PI believes increase risk to safety or ability to complete study\n* Expected concomitant use of aminoglycoside antibiotics","100 Years",{"count":463,"type":21},224,[407],"Background:\n\nCisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might reduce the risk of cisplatin-induced hearing loss.\n\nObjective:\n\nTo find out if atorvastatin reduces hearing loss in people treated with cisplatin and radiation.\n\nEligibility:\n\nPeople ages 18 and older with squamous cell carcinoma of the head and neck who will undergo treatment with cisplatin-based chemotherapy and radiation\n\nDesign:\n\nParticipants will be screened with their medical records.\n\nParticipants currently taking a cholesterol-lowering statin medication are invited to participate in the observational arm of the study. Those not taking such a medication are invited to participate in the interventional arm of the study.\n\nAll participants will have 3 study visits for the purpose of evaluating hearing. One before starting cisplatin treatment, one within 3 months of completing cancer treatment, and one within 2 years of completing cancer treatment. They will have tympanograms. A small flexible tip will be placed in the ear canal. A puff of air will be delivered to assess mobility of the ear drum. They will have hearing tests. They will wear headphones. They will listen to tones that vary in loudness. They will be asked to indicate when they hear a sound. They will complete 3 questionnaires at the time of each hearing test.\n\nParticipants will have 2 visits for blood tests. These will occur upon consent and 12 weeks after. They will be randomly assigned to take the study drug or placebo orally, once daily. They will take it during cisplatin treatment and for 3 months after treatment.\n\nLong-term follow up will include a chart review 2 years after participants complete their cisplatin therapy.",[25,467],"Head and Neck Cancer",[148,469,470,471],"Statin","Chemotherapy","Squamous Cell Carcinoma","2026-06-04",{"date":474,"type":37},"2026-06-05",{"date":476,"type":37},"2024-07-10",{"date":478,"type":21},"2030-08-31",{"name":43,"class":44},5,{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":107,"sex":16,"minAge":4,"maxAge":54,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":499,"locationsCount":45},"100639524","hearing-and-brain-development-cohort-in-children-and-adolescents-100639524","NCT07625462","Hearing and Brain Development Cohort in Children and Adolescents","A Longitudinal Cohort Study of Hearing and Brain Development in Children and Adolescents With Hearing Loss Across Different Hearing Management Pathways and in Normal-Hearing Controls","HBD-Cohort","Inclusion Criteria:\n\n* Age no more than 18 years.\n* For the HA\u002FCI\u002FABI\u002FGT\u002FFU groups: behavioral or pure-tone hearing threshold \\>=20 dB HL, or air-conduction ABR \\>=35 dB nHL; For the normal-hearing control group: participants diagnosed as normal hearing by experienced physicians.\n\nExclusion Criteria:\n\n* Inability to cooperate with study testing procedures.",{"count":490,"type":21},5000,"This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as in a normal-hearing control group. Participants will undergo longitudinal assessments of hearing, speech, language, neurodevelopment, and multimodal brain function.",[25],"2026-06-03",{"date":472,"type":37},{"date":496,"type":21},"2026-05-20",{"date":498,"type":21},"2030-12-31",{"name":500,"class":99},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University",{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":107,"sex":16,"minAge":54,"maxAge":344,"enrollmentInfo":507,"targetDuration":4,"studyType":57,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":72},"100551891","perception-of-speech-in-context-by-listeners-with-healthy-and-impaired-hearing-100551891","NCT06465979","Perception of Speech in Context by Listeners With Healthy and Impaired Hearing","Inclusion Criteria:\n\n* Be able to recognize spoken words in English\n* Be a competent speaker of north American English\n* Be an adult between the age of 18 to 65 years\n* Have normal audiometric thresholds below 25 decibels hearing loss (dB HL) at frequencies between 250 and 8000 Hz OR have audiometric thresholds not exceeding 40 dB HL at frequencies between 250 and 8000 Hz OR have audiometric thresholds not exceeding 55 dB HL at frequencies between 250 and 8000 Hz OR use a cochlear implant\n* Lack language-learning or other cognitive disabilities\n\nExclusion Criteria:\n\n* Inability to recognize spoken words in English\n* Not a competent speaker of north American English\n* Be younger than 18 years of age\n* Be older than 65 years of age\n* Have normal audiometric thresholds exceeding 25 dB HL at frequencies between 250 and 8000 Hz OR have audiometric thresholds exceeding 40 dB HL at frequencies between 250 and 8000 Hz OR have audiometric thresholds exceeding 55 dB HL at frequencies between 250 and 8000 Hz\n* Language-learning or other cognitive disabilities",{"count":508,"type":21},680,[59],"Recognition of speech sounds is accomplished through the use of adjacent sounds in time, in what is termed acoustic context. The frequency and temporal properties of these contextual sounds play a large role in recognition of human speech. Historically, most research on both speech perception and sound perception in general examine sounds out-of-context, or presented individually. Further, these studies have been conducted independently of each other with little connection across labs, across sounds, etc. These approaches slow the progress in understanding how listeners with hearing difficulties use context to recognize speech and how their hearing aids and\u002For cochlear implants might be modified to improve their perception. This research has three main goals. First, the investigators predict that performance in speech sound recognition experiments will be related when testing the same speech frequencies or the same moments in time, but that performance will not be related in further comparisons across speech frequencies or at different moments in time. Second, the investigators predict that adding background noise will make this contextual speech perception more difficult, and that these difficulties will be more severe for listeners with hearing loss. Third, the investigators predict that cochlear implant users will also use surrounding sounds in their speech recognition, but with key differences than healthy-hearing listeners owing to the sound processing done by their implants. In tandem with these goals, the investigators will use computer models to simulate how neurons respond to speech sounds individually and when surrounded by other sounds.",[28,25],[513,514],"speech perception","hearing",{"date":493,"type":37},{"date":517,"type":37},"2023-09-19",{"date":519,"type":21},"2028-07-31",{"name":521,"class":99},"Marquette University",{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":57,"phases":533,"briefSummary":534,"conditions":535,"keywords":538,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":100},"100637338","maximizing-quality-of-life-after-cancer-through-rehabilitation-100637338","NCT07622407","Maximizing Quality of Life After Cancer Through Rehabilitation","A Transdisciplinary Interventions to MaximizE QuaLitY of Life After Cancer Through REHABilitation (TIMELY REHAB)","TIMELY REHAB","Inclusion Criteria:\n\nParticipants must be:\n\n* diagnosed with head and neck malignancy within the past 60 days;\n* prescribed a treatment plan at participating site that includes at least 1 dose of a cisplatin-based chemotherapy, or at least one dose of radiotherapy and\u002For surgery;\n* prescribed Intensive Dysphagia Therapy (IDT) at the participating site;\n* sufficient fluency in written English to be able to complete the study patient reported outcome questionnaires.\n\nExclusion Criteria:\n\nParticipants will be excluded is they have:\n\n* distant metastasis at enrollment;\n* diagnosis of second primary non-head and neck cancer in the thorax or the central nervous system at enrollment;\n* prior or planned total laryngectomy;\n* prior or planned cochlear implant;\n* head and neck radiotherapy for thyroid or cutaneous\u002Fskin primary tumors, regardless of neck fields;\n* cognitively or physically unable to participate (patient, physician or nurse report patient is incapable of participating), medical records indicate that participant exhibits aggressive behavior, participant has documented dementia, Alzheimer's disease, or severe psychosocial disorder, or notes indicate an individual is not legally capable of providing informed consent (participant has a legal guardian);\n* moderate\u002Fsevere dysphagia at enrollment per baseline videofluoroscopy DIGEST grade \\>=2;\n* severe\u002Fprofound hearing loss at enrollment per baseline audiogram;\n* exhibits Meniere's disease or retrocochlear disorder based on baseline hearing test results, patient report or notes in electronic medical records;\n* exhibits active or recent history of middle ear disorder based on otoscopy, tympanometry, baseline hearing test results, patient report, or medical record documentation;\n* unwilling to participate.","89 Years",{"count":532,"type":21},74,[59],"Treatment for head and neck cancer (HNC) often includes cisplatin chemotherapy and radiation. This treatment causes hearing loss and trouble swallowing in 70% of patients. If untreated, these symptoms increase stress and lower quality of life for survivors. Veterans with HNC usually get help for swallowing. However, damage to the hearing and balance systems-known as ototoxicity-is often missed or only addressed when it becomes very severe. To fill this gap, the investigators plan a clinical trial at two VA sites. The investigators compare the usual swallowing therapy alone to a new, more comprehensive program. This new program includes:\n\n1. the standard swallowing therapy,\n2. proactive management to protect hearing and balance or manage problems that can't be prevented, and\n3. other rehabilitation services based on a tele-oncology nurse's assessment. The hearing and balance intervention features quick screening tests and validated questionnaires to identify early signs of damage. These are given during cancer or radiation treatment visits to maximize convenience for the patient. Audiologists review these results remotely using tele-health technology. The investigators will also use new tools to predict and spot hearing problems that are personalized for each patient. The audiologist works closely with the patient and the care team to arrange further help if needed.\n\nThe tele-oncology nurse checks for other rehabilitation needs using a screening tool validated in Veterans, shares this information with the team, and advises patients about recommended care.\n\nThe investigators expect the results to show that managing hearing loss with swallowing therapy while improving care coordination for rehabilitation reduces survivors' stress and improves well-being compared to swallowing therapy alone.",[467,25,536,537],"Tinnitus","Dysphagia",[31,470,539,540,467,541,537,542,543,536],"Cisplatin","Drug-related side effects and adverse reactions","Ototoxicity","Professional practice gaps","Sensorineural hearing loss","2026-05-27",{"date":493,"type":37},{"date":547,"type":21},"2027-03-01",{"date":549,"type":21},"2030-06-30",{"name":551,"class":552},"VA Office of Research and Development","FED",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":57,"phases":563,"briefSummary":564,"conditions":565,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":572,"locationsCount":45},"100641008","hearing-outcomes-with-the-nucleus-8-sound-processor-and-nucleus-7-sound-processor-in-adult-veteran-and-non-veteran-cochlear-implant-recipients-100641008","NCT07582198","Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients","A Post-market Interventional, Prospective, Open-label, Multi-center, Clinical Investigation of Hearing Outcomes With the Nucleus 8 Sound Processor and Nucleus 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients","SALUTE","Inclusion Criteria:\n\n1. Aged 18 years or older, at time of consent.\n2. Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24R(CA), CI24R(ST) CI24R(CS), CI24M, CI24RE(CA), CI24RE(ST), CI422) in the test ear.\n3. At least 18 active electrodes in the test ear.\n4. At least 6 months experience with a cochlear implant in the test ear.\n5. Able to score 20% or more at +10 dB SNR with CI alone on an S0N0 sentence in-noise test in the test ear.\n6. Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.\n7. Candidate is a fluent speaker in the language used to assess speech perception performance.\n8. Direct access to a compatible smartphone.\n9. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Recipients with single-sided deafness as determined by the Investigator.\n2. Additional disabilities that would prevent participation in evaluations.\n3. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.\n4. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.\n5. Investigator site personnel directly affiliated with this study and\u002For their immediate families; immediate family is defined as a spouse, parent, child, or sibling.\n6. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.\n7. Current participation, or participation in another interventional clinical study\u002Ftrial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).",{"count":562,"type":21},26,[59],"The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants.\n\nThe study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community.\n\nParticipants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.",[25],"2026-05-06",{"date":568,"type":37},"2026-05-12",{"date":570,"type":21},"2026-05",{"date":311,"type":21},{"name":70,"class":71},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":107,"sex":16,"minAge":245,"maxAge":580,"enrollmentInfo":581,"targetDuration":4,"studyType":57,"phases":583,"briefSummary":584,"conditions":585,"keywords":586,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":596,"completionDateStruct":597,"leadSponsor":599,"locationsCount":45},"100484855","school-screening-and-telemedicine-specialty-referral-to-address-childhood-hearing-loss-in-rural-alaska-100484855","NCT05593484","School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Alaska","North STAR Trial: Specialty Telemedicine Access for Referrals (STAR) in Rural Alaska","Inclusion Criteria:\n\n* Enrolled in one of the participating schools in the 3 regions\n* Children from grades (K-12) that are typically screened within participating schools\n* Eligible regardless of age, gender, race, or ethnicity\n\nExclusion Criteria:\n\nN\u002FA","21 Years",{"count":582,"type":21},8060,[59],"The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments.\n\nWe will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school.\n\nThis stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \\~2,015 K-12 students\u002Fyear). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years.\n\nTimeline update: Based on feedback from community partners, we extended the trial for one year to allow for community-informed adaptations of the enhanced screening. Now the STAR intervention will be rolled out in 2025-2026 for sequence 1 and 2026-2027 for sequence 2.",[25],[587,588,589,590,591,592,593],"Rural","Hearing loss","Telemedicine","Telehealth","School","Disparities","Screening","2026-05-04",{"date":566,"type":37},{"date":122,"type":37},{"date":598,"type":21},"2027-06-30",{"name":600,"class":99},"University of Arkansas",{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":107,"sex":16,"minAge":245,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":57,"phases":611,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":621,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":625,"locationsCount":45},"100478735","school-screening-and-telemedicine-specialty-referral-to-address-childhood-hearing-loss-in-rural-kentucky-100478735","NCT05513833","School Screening and Telemedicine Specialty Referral to Address Childhood Hearing Loss in Rural Kentucky","Appalachian Specialty Telemedicine Access for Referrals (STAR) Trial","Inclusion Criteria:\n\n* Enrolled in school in one of the 14 participating counties\n* Initial entry into elementary school\n* Eligible regardless of age, gender, race, or ethnicity\n\nExclusion Criteria:\n\n• N\u002FA","11 Years",{"count":610,"type":21},18000,[59],"This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.",[25],[587,514,615,616,617,618,619,620],"loss","telemedicine","telehealth","school","disparities","screening",{"date":566,"type":37},{"date":623,"type":37},"2022-09-01",{"date":598,"type":21},{"name":600,"class":99},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":16,"minAge":191,"maxAge":344,"enrollmentInfo":634,"targetDuration":4,"studyType":57,"phases":636,"briefSummary":638,"conditions":639,"keywords":663,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":681,"locationsCount":45},"100616316","phase-1-a-treatment-for-a-form-of-age-related-central-auditory-processing-disorder-consisting-of-clemastine-fumarate-plus-engineered-sound-100616316","NCT07304024","A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound","A Double-Blinded, Placebo-Controlled, Randomized, Phase 1\u002F2a Clinical Study to Test the Safety and Efficacy of a Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound","CAPD-LOOT","Inclusion Criteria:\n\n* Male or female between 45 and 65 years old (middle aged) at the screening\u002Fenrollment visit (Visit 1).\n* Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.\n* Documentation of no more than a mild high-frequency hearing sensitivity loss and normal middle-ear function will be obtained using standard audiometric equipment with measurements done by an audiologist; Specifically, testing will show:\n\n  * bilateral hearing thresholds \\\u003C 20 dB HL at audiometric frequencies from 250 Hz to 4000 Hz inclusively, with no air-bone gaps \\> 10 dB.\n  * symmetrical hearing thresholds between the ears through 8000 Hz, defined as \\\u003C20 dB difference at any single audiometric frequency or \\\u003C 15 dB difference at 2 or more contiguous frequencies.\n  * normal (Type A) tympanograms bilaterally.\n* No cognitive deficit shown upon screening with the Montreal Cognitive Assessment (MOCA) test (Nasreddine et al. 2005).\n* Distortion product otoacoustic emission (DPOAE) showing no more than 20 dB hearing loss at audiometric frequencies from 250 Hz to 4000 Hz.\n* Subjects failing the hearing in noise test at 15 degrees. Failing is defined as SNR being 12 dB below from what is found in normal hearing subjects without central hearing loss.\n\nExclusion Criteria:\n\n* Any subjects who do not fall under the criteria defined above.\n* Any of the following conditions which are listed as contraindications or warnings for use of the clinical trial drug (from labeling):\n\n  * Known sensitivity to clemastine fumarate or other antihistamines of similar composition\n  * Pregnancy or nursing mother as determined objectively with a urine pregnancy test\n  * Lower respiratory tract disease including asthma, or breathing difficulties such as emphysema or chronic bronchitis\n  * Glaucoma or increased intraocular pressure\n  * Stenosing peptic ulcers or pyloroduodenal obstruction\n  * Trouble urinating due to an enlarged prostate gland. Mild urinary issues (Stage 1 Benign Prostatic Hyperplasia) will not be considered an automatic exclusion but it must be emphasized to patients with this diagnosis that difficulty urinating is a possible side effect that may compound their BPH symptoms.\n  * Significant cardiovascular disease, chronic hypertension or hypotension\n  * Hyperthyroidism\n  * Alcoholism- as defined by consuming on average 3+ drinks per day for women or 4+ drinks per day for men or previous diagnosis of alcohol use disorder by a clinician as defined by DSM V criteria.\n  * Patients with a history of seizures will be excluded.\n  * Patients with evidence of suicidal ideation\u002Fbehavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).\n* We will generally exclude subjects with significant or uncontrolled medical disorders (e.g., hepatic, hematologic, renal, gastrointestinal, neurological, psychiatric disorders). We will define these patients as those who fall outside of normal ranges for a physical examination of vital signs, a 12-lead EKG, and a safety clinical laboratory assessment including complete blood count (CBC) and comprehensive metabolic panel (CMP). Exclusion with these tests will specifically focus on identifying the following disorders based on the listed criteria:\n* Leukopenia as defined as a CBC white blood cell count \\\u003C 4000\u002Ful\n* Anemia as defined by a CBC Hemoglobin \\\u003C9.0 g\u002FdL or \\\u003C10.0 g\u002FdL (Grade 2+ CTCAE)\n* Lymphopenia as defined by CBC Absolute lymphocyte count \\\u003C1000\u002FµL.\n* Neutropenia as defined by CBC ANC \\\u003C1500\u002FµL (solid tumors), ANC \\\u003C1000\u002FµL (hematologic malignancies). In the case of participants with African, Middle Eastern or West Indian descent a clinician's judgement will be considered to assess the possibility of benign ethnic neutropenia which is not an exclusion criteria.\n* Thrombocytopenia as defined by CBC Platelet count \\\u003C75000\u002FµL\n* Hepatic Impairment based on CMP: Total bilirubin \\>1.5× ULN, AST\u002FALT \\>3× ULN (or \\>5× ULN if liver metastases), Alkaline phosphatase \\>3× ULN.\n* Hepatic Impairment based on CMP: Serum creatinine \\>2.0 mg\u002FdL (alternative threshold).\n* Metabolic abnormalities based on CMP: Albumin \\\u003C3.0 g\u002FdL\n* Taking medications that would contraindicate taking the clinical trial drug; Specifically, (from labeling):\n\n  * Monoamine oxidase inhibitor therapy\n  * CNS depressants (sedatives, tranquilizers, hypnotics)\n* A history of significant otologic disorder such as repetitive ear infections or Meniere's disease\n* A history of significant neurologic disorder, or current neurodegenerative diseases such as multiple sclerosis, which could present a confound and impact the electrophysiological outcome measures.\n* A history of traumatic brain or closed head injury because this can cause symptoms of central auditory processing problems unrelated to aging and demyelination.\n* English as a second language (non-native English speakers), which is known to negatively impact scores on speech recognition testing.\n* Presence of any other condition or abnormality that in the opinion of the Investigator or his co-PIs would compromise the safety of the patient or the quality of the data.",{"count":635,"type":21},344,[637,407],"PHASE1","The goal of this clinical trial is to determine the efficacy of Clemastine Fumarate in the presence of engineered sound to treat age-related central auditory processing disorder (CAPD). This disorder impacts 800M patients worldwide, including \\~1\u002F3 people over 40 years of age and \\~1\u002F2 people over 65, resulting in an inability to hear in noisy environments.\n\nThe primary hypothesis this study aims to test is: engineered sound, driving localized neural circuit activity, will enable Clemastine Fumarate to mature Oligodendrocyte cells and thus remyelinate these activated neural circuits. This Localized Oligodendrocyte Optimization Therapy (LOOT) was highly effective in preclinical animal studies so this clinical trial aims to answer if this therapy will translate to humans.\n\nThe study is an adaptive design intended to compare the efficacy of the drug in the presence or absence of the engineered sound for improving hearing in noise ability. Trial participants will be tested for hearing thresholds and ability to isolate a sound signal from background noise. If they meet the inclusion criteria, they will be enrolled into one of the four arms of the study and undergo the proposed one-month treatment (drug and sound or respective placebos). After the treatment period, trial participants will be tested again for hearing thresholds and their ability to isolate s sound source of interest from background noise. The hypothesis to be tested in this clinical trial is that the one-month treatment will significantly improve the participant's ability to isolate a sound source of interest from background noise.\n\nThe design has four arms, drug+sound, placebo+sound, drug+white noise, and placebo+white noise. Based on our preclinical data, control arms are all expected to show identical results, thus our adaptive design includes interim analyses to allow for dropping of two of the three placebo arms should the preclinical results be replicated as anticipated.\n\nWe will also monitor each participant's general health during the duration of the clinical trial, which will be done by performing a number of blood tests, an EKG and a general physical before and after the one-month treatment period. We expect no significant changes since participants will take the drug for the one-month period at dosages already demonstrated safe in several Phase II studies of multiple sclerosis. Similarly, the engineered sound will be listened to for one hour per day during this month at sound intensities well below threshold that might cause noise-induced hearing damage.",[640,641,28,642,643,644,645,646,647,648,169,25,649,650,651,652,653,654,655,656,657,658,659,660,661,662],"Central Auditory Processing Disorder","Hearing Impaired (Partially)","Hearing Abnormality","Hearing Disability","Hearing Disorder","Hearing Disorders","Hearing Impairment, Sensorineural","Hearing Handicap","Hearing Impaired","Central Auditory Disease","Noise Exposure","Noise Induced Hearing Loss","Noise-Induced Hearing Loss","Sound Perception","Myelin Degeneration","Myelinopathy","Myelin Integrity","Remyelination","Hidden Hearing Loss","Cocktail Party Skill","Cocktail Party Syndrome","CAPD","Age Problem",[664,658,665,666,667,668,669,670,671,672,661,673],"clemastine fumarate","Cocktail Party","Engineered Sound","Sound Therapy","central auditory processing disorder","Hearing in noise","oligodendrocyte","Localized Oligodendrocyte Optimization Therapy","LOOT","Age-Related Hearing Loss","2026-04-28",{"date":676,"type":37},"2026-04-30",{"date":678,"type":37},"2025-03-31",{"date":680,"type":21},"2028-07",{"name":682,"class":99},"University of Colorado, Denver",{"id":684,"slug":685,"hasResults":12,"nctId":686,"briefTitle":687,"officialTitle":688,"acronym":4,"eligibilityCriteria":689,"healthyVolunteers":12,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":690,"targetDuration":4,"studyType":57,"phases":692,"briefSummary":693,"conditions":694,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":702,"locationsCount":45},"100593860","extra-cochlear-electrode-placement-at-the-post-auricular-vagus-nerve-in-cochlear-implantation-100593860","NCT07011927","Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation","Single-center Non-inferiority Study of Extra-cochlear Electrode Placement at the Post-auricular Vagus Nerve in Cochlear Implantation","Inclusion Criteria:\n\n* will be undergoing surgery for a cochlear implant from Cochlear Americas\n* is willing to participate in the study\n\nExclusion Criteria:\n\n* has history of prior ear surgery, congenital ear malformation, or prior cochlear implantation in the ear to be implanted\n* pregnant, planning to become pregnant, or breastfeeding patients cannot undergo the standard-of-care implantation procedures required for participation in the study.",{"count":691,"type":21},12,[59],"This study will evaluate hearing outcomes after cochlear implantation with placement of the ECE1 ground electrode near the post-auricular vagus nerve (Arnold's nerve) to assess non-inferiority with respect to placement under the temporalis muscle.",[25],"2026-04-27",{"date":697,"type":37},"2026-05-01",{"date":699,"type":37},"2025-10-17",{"date":701,"type":21},"2028-07-01",{"name":703,"class":99},"NYU Langone Health"]