[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100529458":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":55,"collaborators":58,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":23,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":41,"whyStopped":23,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Columbia University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Hearing Intervention","Participants will receive 4 sessions across 8 weeks with a later booster session and hearing aid fitting. Each session will take \\~75 minutes.",[12],"Device: Hearing Intervention",{"label":14,"type":6,"description":15,"interventionNames":16},"Health Education Intervention","Participants will receive a modified health education program on healthy aging. It will match the number and length of sessions as the hearing intervention, including compliance\u002Fphone checks. Participants will be on a waitlist to obtain hearing aids without fee at the end of their 12-month participation.",[17],"Behavioral: Health Education Intervention",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","The hearing intervention includes an auditory needs assessment, hearing aid fitting, establishing Bluetooth connectivity from hearing aids to devices such as smartphones and computers, systematic orientation and instruction in device use, and provision and discussion of hearing \"toolkit\" materials for self-management and communication strategies. The hearing intervention is person-centered, focusing on identification of individual needs, setting of specific goals, engagement in shared-informed decision-making, and development of self-management abilities. Intervention-centric outcomes (e.g., hearing aid data logging, real ear measures) to verify the best-practices intervention will be gathered at all 5 intervention sessions as well as weeks 16 and 52. Additional visits to troubleshoot hearing aids or address concerns will be scheduled as needed.",[9],null,{"type":25,"name":14,"description":26,"armGroupLabels":27,"otherNames":23},"BEHAVIORAL","The evidence-based interactive health education program is designed for older adults and addresses chronic disease and disability prevention. Session content will be individualized for each participant based on a \"key,\" depending on his\u002Fher goals\u002Finterests. The curriculum includes didactics, activities, and goal setting led by staff trained\u002Fcertified to deliver the intervention.",[14],[29],{"name":30,"affiliation":5,"role":31},"Justin S Golub, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":23,"email":37},"Larry Tapia","CONTACT","646-317-3252","earhli@cumc.columbia.edu",[39],{"facility":40,"status":41,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Columbia University Medical Center","RECRUITING","New York","10032","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.00597,40.71427,{"lat":50,"lon":49},[53,54],{"name":34,"role":35,"phone":36,"phoneExt":23,"email":37},{"name":30,"role":31,"phone":23,"phoneExt":23,"email":23},{"type":31,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Justin S. Golub","Associate Professor of Otolaryngology\u002FHead and Neck Surgery",[59,61,64,66,68],{"name":60,"class":6},"Johns Hopkins University",{"name":62,"class":63},"National Institute on Aging (NIA)","NIH",{"name":65,"class":6},"University of South Florida",{"name":67,"class":6},"University of Pittsburgh",{"name":69,"class":6},"University of Washington","100529458","early-age-related-hearing-loss-investigation-earhli-100529458",false,"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","ALL","55 Years","75 Years",{"count":82,"type":83},150,"ESTIMATED","INTERVENTIONAL",[86],"NA","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).",[89,90,91],"Alzheimer Disease","Hearing Loss","Cognitive Impairment",[90,93,94,95,96,97,98,99],"Alzheimer's","Alzheimer","Hearing Aid","Memory Loss","Memory","Audiogram","Cognition","2026-08-10",{"date":102,"type":103},"2026-08-12","ACTUAL",{"date":105,"type":103},"2024-08-01",{"date":107,"type":83},"2027-12-31",{"name":5,"class":6},1]