[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of South Florida\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":697},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,49,0,25,[9,42,79,107,137,162,193,226,249,279,305,341,372,400,427,449,472,496,513,542,565,600,618,644,672],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100631568","phase-4-effect-of-acoltremon-ophthalmic-solution-0003-on-signs-and-symptoms-of-ocular-surface-disease-in-stage-i-neurotrophic-keratopathy-patients-with-tear-deficiency-100631568",false,"NCT07502378","Effect of Acoltremon Ophthalmic Solution 0.003% on Signs and Symptoms of Ocular Surface Disease in Stage I Neurotrophic Keratopathy Patients With Tear Deficiency","Inclusion Criteria:\n\n* Neurotrophic Keratopathy stage 1 diagnosis based on the following: Presence of 3+ fluorescein staining in central cornea and decreased corneal sensation (Cochet-Bonnet less than 4cm in the central cornea)\n* Baseline unanesthetized Schirmer's test ≤ 10 mm\n* Females of childbearing potential must have a negative pregnancy test.\n* Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen \\\u003C20\u002F200).\n\nExclusion Criteria:\n\n* Evidence of any active ocular infection or any intraocular inflammation.\n* Evidence of any persistent epithelial defect\u002Fulcer or any corneal scar\u002Fcorneal edema.\n* Presence of any other ocular conditions that require topical medications during the treatment phase.\n* History of severe systemic allergies or severe ocular allergies.\n* Inability to suspend topical medications 8 days prior to the starting date and artificial tears 2 hours prior to the first study visit and remain off for the duration of the study.\n* History of any ocular surgery within three months before study visit 1.\n* Ocular surgery expected during the duration of the study.\n* Use of refractive\u002Ftherapeutic contact lenses during the study period.\n* Female subjects who are pregnant\u002Fhave a positive pregnancy test result or are breastfeeding or intend to become pregnant during the study treatment period.\n* Drug addiction\u002Falcohol abuse.\n* Participation in another clinical trial concurrently","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","STUDY OBJECTIVE To assess if acoltremon 0.003% improves tear production in patients with Stage 1 Neurotrophic Keratopathy.",[26,27],"Ocular Surface Disease","Neurotrophic Keratopathy Stage 1",[26],"RECRUITING","2026-08-11",{"date":32,"type":33},"2026-08-12","ACTUAL",{"date":35,"type":33},"2026-04-06",{"date":37,"type":20},"2027-08-31",{"name":39,"class":40},"University of South Florida","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":41},"100651821","spatial-cues-task-demands-and-auditory-selective-attention-100651821","NCT07765186","Spatial Cues, Task Demands, and Auditory Selective Attention","How Spatial Cues Support Communication: Interactions Between Auditory Spatial Features and Task Demands Across Cortical Networks","Inclusion Criteria:\n\n* Adults with normal hearing, confirmed by audiometric assessment (thresholds within 20 dB HL of normal through 8 kHz), OR adults with bilateral cochlear implants who have used their implants for at least one year\n* Native speakers of American English\n* Normal or corrected-to-normal vision\n\nExclusion Criteria:\n\n* Known neurological disorders\n* For fMRI sessions (normal-hearing participants only): contraindications to MRI scanning; cochlear implant users do not complete MRI sessions",true,"90 Years",{"count":52,"type":20},80,[54],"NA","Understanding speech in restaurants and other noisy environments is the most common complaint from the more than 60 million Americans with hearing impairment. Succeeding in such environments requires a listener to first segregate sound sources and then selectively attend to the source of interest. This study examines how individual auditory spatial cues (interaural time differences and interaural level differences) support spatial selective attention, the cortical processes that underlie this ability, and how these processes are modulated by task demands. Participants with normal hearing and participants who use bilateral cochlear implants will perform listening tasks while brain and physiological responses are recorded (electroencephalography, functional near-infrared spectroscopy, pupillometry, and, for normal-hearing participants only, functional magnetic resonance imaging). The findings will provide new insights into the mechanisms of spatial selective attention and help guide clinical solutions for cochlear implant users, individuals with hearing impairment more generally, and older normal-hearing adults who have difficulty understanding speech in noisy environments.",[57,58,59],"Bilateral Cochlear Implants","Hearing Loss, Bilateral","Healthy",[61,62,63,64,65,66,67,68,69,70],"spatial hearing","auditory selective attention","interaural level difference","interaural time difference","cochlear implant","EEG","fNIRS","fMRI","pupillometry","speech in noise","2026-08-10",{"date":73,"type":33},"2026-08-14",{"date":75,"type":33},"2025-10-22",{"date":77,"type":20},"2030-07",{"name":39,"class":40},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100650624","brain-dopamine-biomarker-100650624","NCT07748715","Brain Dopamine Biomarker","Blue Color Processing in the Eye as a Biomarker of Brain Dopamine","B3-4D","Inclusion Criteria:\n\n* Parkinson's subjects will have received physician verified diagnosis of the disease and be on a dopaminergic medication for at least 3 months\n\nExclusion Criteria:\n\n* Any movement, strength, or balance assessments that may pose a potential risk for injury\n* Individuals with a history of photosensitive epilepsy or seizure activity triggered by visual stimuli\n* Current use of antipsychotics, stimulants, or other medications known to affect central dopaminergic transmission\n* Pregnancy\n* Recent ocular surgery\n* Phenylketonuria\n* (PD participants) not cognitively intact and not able to consent for themselves\n* (non-PD subjects) a pre-screening survey will assess medication use and neurological history\n* Ophthalmologic or visual system conditions that may interfere with stimulus delivery or retinal function. These include significant cataract (defined as LOCS III ≥ NC2\u002FNO2 or any media opacity that precludes adequate delivery of visual stimuli to the retina), active retinal or macular pathology (including age-related macular degeneration with significant drusen or geographic atrophy, diabetic retinopathy, retinal vein occlusion, or epiretinal membrane with foveal involvement), glaucoma, or any optic neuropathy.\n* Individuals with congenital color vision deficiencies, particularly tritan-spectrum defects\n* Ocular surgery within the past three months\n* Use of medications known to affect retinal electrophysiology (e.g., chronic hydroxychloroquine, vigabatrin, deferoxamine, or isotretinoin)\n* History of photosensitive epilepsy or visually triggered seizures (especially relevant given the use of bright visual stimuli and potential flicker paradigms)",{"count":19,"type":20},"OBSERVATIONAL","This study is being conducted at the Morsani College of Medicine to determine whether signals recorded from the eyes and brain can be used as a noninvasive way to monitor dopamine function. Approximately 50 adults (25 with Parkinson's disease and 25 without Parkinson's disease) will participate. Participants will undergo electroretinography (ERG) and electroencephalography (EEG), which are FDA-approved, noninvasive devices that measure electrical activity from the retina and brain using sensors placed on the skin around the eyes and scalp. Participants with Parkinson's disease will be tested before and after taking their prescribed Parkinson's medication (e.g., Sinemet® \\[carbidopa\u002Flevodopa\\]). Participants without Parkinson's disease will receive a single dose of compounded levodopa\u002Fcarbidopa eye drops (an FDA-approved drug used in an unapproved ophthalmic formulation) in one eye and a placebo eye drop in the other eye. The placebo consists of the same vehicle solution without levodopa\u002Fcarbidopa and contains 0.1% ascorbic acid, 0.001% benzalkonium chloride, and phosphate-buffered saline. Randomization will be used to determine which eye receives the levodopa\u002Fcarbidopa eye drop and which eye receives the placebo. Researchers will compare measurements obtained before and after treatment to evaluate whether blue-light visual responses are associated with dopamine activity.",[91,92],"Parkinson Disease","Healthy Adult Participants",[94,95,96,97,98,99],"dopamine","retina","biomarker","brain","electroretinography","blue light","NOT_YET_RECRUITING",{"date":32,"type":33},{"date":103,"type":20},"2026-10-01",{"date":105,"type":20},"2027-09-30",{"name":39,"class":40},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},"100633644","pharmacist-led-continuous-glucose-monitoring-for-prediabetes-100633644","NCT07529366","Pharmacist-Led Continuous Glucose Monitoring for Prediabetes","Redefining Prediabetes Care: Pharmacist-Led Continuous Glucose Monitoring to Drive Lifestyle Change","Inclusion Criteria:\n\n* adults 18-70 years of age\n* prediabetes (HbA1c 5.7-6.4%)\n* compatible smartphone with the Dexcom Stelo sensor system\n* have not have worn a CGM in the last 6 months prior to enrollment\n\nExclusion Criteria:\n\n* any of the following forms of diabetes: type 1 diabetes, type 2 diabetes, monogenic diabetes, cystic fibrosis-related diabetes, post- transplant diabetes, latent autoimmune diabetes\n* problematic hypoglycemia in the prior 6 months \\[defined as recurrent (more than one) level 2 hypoglycemic events (glucose \\\u003C54mg\u002FdL ) that persist despite multiple attempts to adjust medication(s) and\u002For modify the diabetes\u002Ftreatment plan or a history of one level 3 hypoglycemic event (glucose \\\u003C54mg\u002FdL) characterized by altered mental and\u002For physical state requiring third-party assistance for treatment of hypoglycemia\\]\n* pregnant, or planning to become pregnant during the study time frame\n* currently receiving or planned to receive dialysis during the study time frame - current use of systemic steroids for any condition\n* a known allergy to medical grade adhesives,\n* use of any CGM device in the past 6 months\n* history of a diagnosed eating disorder\n* current use of a second-generation antipsychotic at the time of consent (aripiprazole, asenapine, brexpiprazole, cariprazine, clozapine, iloperidone, lurasidone, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone)\n* subjects lacking capacity to provide informed consent","70 Years",{"count":116,"type":20},40,"The goal of this observational study is to determine if a pharmacist-led program involving continuous glucose monitoring (CGM) improves glucose control and health behavior in people with prediabetes. The main questions it aims to answer are:\n\n1. Determine impact of pharmacist-led CGM on glycemic control in people with prediabetes. Researchers will compare change in hemoglobin A1c at 12 weeks with pharmacist-led CGM versus a historical cohort of subjects with prediabetes receiving no CGM. The investigators will also assess change in CGM-derived glycemic metrics from baseline to end of the CGM wear period in the intervention group.\n2. Evaluate impact of pharmacist-led CGM on health behavior change in people with prediabetes in the intervention group. Participants will be asked to complete the Summary of Diabetes Self-Care Activities Measure (SDSCA) and 36-Item Short Form Health Survey (SF-36) at baseline, at the end of week 4, and at the end of the study so that researchers can measure the effects in the intervention group on health behavior change.",[119],"Prediabetes",[121,122,123,124,125,126,127,128],"prediabetes","continuous glucose monitoring","pharmacist","health behavior","Hemoglobin A1c","endocrinology","primary care","CGM","2026-08-05",{"date":71,"type":33},{"date":132,"type":20},"2026-09-01",{"date":134,"type":20},"2027-07-31",{"name":39,"class":40},2,{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":41},"100631799","behavioral-parent-training-to-address-early-childhood-disruptive-behavior-using-the-docs-parenting-programs-100631799","NCT07505381","Behavioral Parent Training to Address Early Childhood Disruptive Behavior Using the DOCS Parenting Programs","DOCS Parenting: Early Years and School Years","DOCS parenting","Inclusion Criteria:\n\n* caregiver or professional caring for child ages 0-12 years, or\n* caregiver or professional caring for a child enrolled in kindergarten-5th grade.\n* Must speak English or Spanish.\n\nExclusion Criteria:\n\n* Language other than English or Spanish.\n* Caregiver\u002Fprofessional under the age of 18.",{"count":146,"type":20},800,[54],"DOCS Parenting offers group-delivered behavioral parent training interventions for caregivers of children ages 0-12 years.",[150,151,152,153],"Disruptive Behavior","Developmental Disability","Developmental Delay (Disorder)","Behavior Problem of Childhood","2026-08-03",{"date":156,"type":33},"2026-08-06",{"date":158,"type":33},"2018-10-02",{"date":160,"type":20},"2028-09-30",{"name":39,"class":40},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":21,"phases":169,"briefSummary":170,"conditions":171,"keywords":175,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":41},"100619280","the-weact-program-for-family-caregivers-of-people-living-with-dementia-100619280","NCT07342569","The WeACT Program for Family Caregivers of People Living With Dementia","Inclusion criteria\n\nFamily caregivers of people living with dementia will be eligible to participate if they meet all of the following criteria:\n\n1. Are community-dwelling adults aged 18 years or older who have primary caregiving responsibilities for a relative diagnosed with dementia;\n2. Present mild to moderately severe depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9), with scores between 5 and 19; and\n3. Have access to a web-enabled device, such as a smartphone, tablet, laptop, or desktop computer, with internet access.\n\nExclusion criteria\n\nFamily caregivers of people living with dementia will be excluded if they meet any of the following criteria:\n\n1. Have cognitive, physical, or sensory impairments, or are unable to complete study procedures in English, that may impede study participation;\n2. Present severe depressive symptoms, defined as PHQ-9 scores of 20 or higher;\n3. Report having thoughts of harming themselves or attempting suicide within the past six months;\n4. Have previously participated in a research study involving an ACT program;\n5. Are currently participating in another caregiver intervention study; or\n6. Have experienced more than three hospitalizations of either the family caregiver or the relative with dementia within the past year.",{"count":116,"type":20},[54],"The goal of this clinical trial is to learn whether WeACT, a self-paced, web-based program, is feasible and helpful for adult family caregivers of a relative living with dementia. WeACT is based on acceptance and commitment therapy (ACT), which teaches skills to handle difficult thoughts and feelings and take steps toward what matters most.\n\nThe main questions this study aims to answer are:\n\n* Can caregivers complete WeACT as planned?\n* Do caregivers show improvements in mental health and coping after using WeACT?\n* What are caregivers' experiences with the program, and what suggestions do they have to improve it?\n\nParticipants will:\n\n* Complete six self-paced weekly online modules and use the daily practice section during the program.\n* Complete online questionnaires before starting and after completing the program.\n* Take part in one online interview about their experience.",[172,173,174],"Depression","Caregivers","Dementia",[176,177,178,179,180,181,182,183,184,185],"acceptance and commitment therapy","Internet-Based Intervention","caregivers","dementia","depressive symptoms","feasibility","usability","web-based intervention","mixed methods","Pilot Study",{"date":187,"type":33},"2026-08-04",{"date":189,"type":20},"2026-08",{"date":191,"type":20},"2027-02",{"name":39,"class":40},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":210,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100648410","im-able-2-injuries-managed-with-advanced-bracing-for-lower-extremities-100648410","NCT07721792","IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities","The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses","IM ABLE 2","Inclusion Criteria:\n\n* Lower extremity injury of any etiology requiring current use of an AFO\n* Age 18-80 years\n* 100-275 lbs\n* Greater than 1 month of AFO experience\n* Use of an AFO for activities of daily living\n* English or Spanish speaking\n* Able to comply with study procedures\n\nExclusion Criteria:\n\n* Body mass less than 100 or greater than 275 lbs.\n* Over 80 years of age\n* Known cognitive impairment (e.g. diagnoses such as moderate\u002Fsevere traumatic brain injury, dementia)\n* Inability to comply with instructions.\n* Pregnancy\n* Medical conditions that would preclude safe involvement\n* Unable to provide written informed consent.","80 Years",{"count":203,"type":20},75,[54],"The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function.",[207,208,209],"Lower Limb Injury","Ankle Foot Orthosis (AFO)","Lower Limb Trauma",[211,212,213,214,215,216],"Ankle foot orthosis (AFO)","activity monitor","lower limb injury","gait","activities of daily living","lower extremity trauma","2026-07-20",{"date":219,"type":33},"2026-07-23",{"date":221,"type":20},"2026-07-31",{"date":223,"type":20},"2029-01-31",{"name":39,"class":40},3,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":21,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":136},"100599507","balloon-guide-versus-conventional-guide-catheter-in-stroke-thrombectomy-100599507","NCT07085390","Balloon Guide Versus Conventional Guide Catheter in Stroke Thrombectomy","2Guide","Inclusion Criteria:\n\n* Age 18 years or older\n* Patient is undergoing a stroke thrombectomy procedure at the enrolling hospital\n* Patient or the legally authorized representative are able to provide signed informed cosent for the study\n* Patient is not enrolled in another clinical trial that may interfere with the results or interpretation of this study\n* Identification of a Large Vessel Occlusion (LVO) on imaging\n\nExclusion Criteria:\n\n* Lack of signed informed consent from the patient or legally authorized representative\n* Spontanous recanalization or any other reason in which the mechanical thrombectomy procedure would be terminated",{"count":234,"type":20},186,[54],"The purpose of this clinical trial is to study the two main types of approaches used in stroke thrombectomy and to investigate if one approach is more effective than the other, as this is currently not known. This study will be conducted in adults who have been diagnosed with an acute ischemic stroke and who are undergoing a thrombectomy for the treatment of their stroke. The main questions it aims to answer are:\n\n* Does the use of a balloon guide catheter versus a conventional guide catheter lower the time needed to restore blood flow in the blocked vessel in the brain\n* To help researchers better understand the technical, clinical, and procedural outcomes associated with using a balloon guide catheter versus a conventional guide catheter in stroke thrombectomy\n\nParticipants will be asked to\n\n* Share their medical history and imaging data that is collected as part of their routine medical care\n* Undergo a mechanical thrombectomy as part of their routine medical care\n* Answer some questions about their neurological functioning at 3 months (90 days) post hospitalization",[238],"Acute Ischemic Stroke AIS",[240,241],"Ischemic Stroke","Thrombectomy",{"date":243,"type":33},"2026-07-22",{"date":245,"type":33},"2025-08-27",{"date":247,"type":20},"2028-08",{"name":39,"class":40},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":255,"enrollmentInfo":256,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":257,"conditions":258,"keywords":262,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":41},"100431511","pilot-study-to-evaluate-the-long-term-chronic-care-of-patients-who-could-or-do-utilize-an-osseointegrated-device-oid-100431511","NCT04899037","Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)","Inclusion Criteria:\n\n* age 18-85 years\n* community dwelling\n* residency: participants must plan to reside in the local area for the study duration.\n* fluent English-speaker\n* Audiometric hearing impairment: participants must have hearing configuration that could benefit from OID hearing intervention.\n* Mini-Mental State Exam (MMSE) score \\> 23 for individuals with high-school degree or less; Mini-Mental State Exam (MMSE) score \\>25 for individuals with some college or more; participants must be at risk for cognitive decline the range quantified well by neurocognitive testing, and so must be free from more substantial cognitive impairment at baseline.\n* willingness to participant and adhere to the protocol: participants must be willing and able to consent to participate in the study and be willing to commit to adhere to the study protocol for the duration of the study (3 years)\n\nExclusion Criteria:\n\n* self-reported disability in \\>2 or more Activities of Daily Living (ADL)\n* medical contraindication to use of OID; because OIDs will be the primary device used in the hearing intervention, participants with medical contraindications to OID use are excluded","85 Years",{"count":19,"type":20},"The primary objective of the study is to evaluate OID hearing intervention on cognition among patients who could vs. do utilize an OID. We will also evaluate the long-term effects of OID use on secondary outcomes measures (hearing performance, quality-of-life, social interaction, communication, physical functioning, etc)",[259,260,261],"Hearing Loss, Conductive","Hearing Loss, Mixed","Deafness, Unilateral",[263,264,265,266,267,268,269,270,271,272],"osseointegrated device","cognition","hearing loss","neurocognitive","BAHA","Ponto","Osseointegrated Bone-Conducting Hearing Protheses","Osia","Osseointegrated Auditory Device","Auditory Wellness",{"date":243,"type":33},{"date":275,"type":33},"2021-01-29",{"date":277,"type":20},"2027-12",{"name":39,"class":40},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":285,"enrollmentInfo":286,"targetDuration":4,"studyType":21,"phases":288,"briefSummary":290,"conditions":291,"keywords":294,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":41},"100560734","phase-3-hyperbaric-oxygen-treatment-for-veterans-with-traumatic-brain-injury-100560734","NCT06581003","Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury","Inclusion Criteria:\n\n1. U.S. Service Members and Veterans, between 18 and 75 years of age\n2. Ability to read, write, and speak English.\n3. Ability to provide informed consent.\n4. History of TBI. Participants must have a minimum of 1 year post injury and a TBI classified as mild to moderate as determined by with the Ohio State University TBI Identification Method (Bogner, 2009).\n5. Experiencing chronic symptoms of TBI as determined by at least a NSI total score of ≥22 (based on previous work using this score; Harch et al., 2020.\n6. Able to tolerate the HBOT environment lying down for one hour.\n\nExclusion Criteria:\n\n1. Received HBOT within the last 3 months.\n2. Concurrently enrolled in another clinical trial.\n3. Pregnancy or plans to become pregnant during the study period.\n4. Lactating\n5. History of retinal repair\n6. Malignancy:\n\n   1. Active\n   2. Tumor-related chemotherapy within the prior 6 months\n   3. Therapeutic radiation to the central nervous system within the prior year\n7. Current diagnosis of bipolar disorder type I or schizophrenia as determined by responses to inquiry: Have you ever been diagnosed or prescribed medications for bipolar disorder or schizophrenia?\n8. Chronic use of supplemental oxygen or hypoxemia while breathing room air.\n9. Untreated asthma\u002FBronchial obstruction\u002Fpulmonary blebs, recent\u002Funtreated pneumothorax\n10. Congestive heart failure with ejection fraction \\\u003C 40%\n11. Any implanted devices not cleared for hyperbaric pressurization\\*.\n12. Epilepsy and\u002F or seizures\n13. Scuba diving within the previous month\n14. Current suicidal intent as measured by ≥ 3 on the Columbia-Suicide Severity Rating Scale Screener\n15. Trapped gas observed indicating Bronchospasm present Tension Pneumothorax\n16. Evidence of Noncompliant TM (Until corrected)\n17. Evidence of Pneumothorax\n18. Evidence of Upper Respiratory Tract Infections\n19. Signs and symptoms of viral infections, such as high fevers\n20. Emphysema with CO2 retention\n21. Optic Neuritis\n22. Congenital spherocytosis\n23. History of middle ear surgery \u002F disorders\n24. Pneumocephalus\n25. Optional stool samples will not be collected if someone has diarrhea, vomiting, and took antibiotics in the past 30 days.\n26. Antabuse because it predisposes to oxygen toxicity.\n27. Other medications that would predispose to oxygen toxicity or known to increase drug toxicity will also be excluded. These are: Disulfuram, Acetazolamide, Sulfamylon; bleomycin, cisplatin, and doxyrubicin.\n28. Inability to complete MRIs (e.g., claustrophobia, pacemaker, ferromagnetic implants)\\* Exclusion criteria for fMRI optional sub-study only","75 Years",{"count":287,"type":20},420,[289],"PHASE3","The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are:\n\n* Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms? (Aim 1)\n* How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2)\n* Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms? (Aim 3)\n\nExploratory objectives will explore if there are changes in: 1.) cognitive functioning using neuropsychological tests and the National Institutes of Health (NIH) toolbox, 2.) inflammation biomarkers in blood, 3.) microbiome in stool samples, 4.) electroencephalogram (EEG), 5.) sleep characteristics, and 6.) fMRI.\n\nResearch will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen.\n\nParticipants will:\n\n1. Complete baseline assessments to determine eligibility.\n2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks.\n3. Complete questionnaires and interviews throughout the course of the study.\n4. Complete a 2-week post treatment visit",[292,293],"Traumatic Brain Injury","Military Operations",[295,296],"hyperbaric chamber","neuromodulation","2026-07-13",{"date":299,"type":33},"2026-07-15",{"date":301,"type":33},"2024-09-18",{"date":303,"type":20},"2029-08-15",{"name":39,"class":40},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":313,"minAge":314,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":324,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":41},"100625196","utero-ovarian-transposition-in-patients-with-pelvic-malignancies-undergoing-whole-pelvic-radiotherapy-100625196","NCT07419490","Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy","A Phase I Assessment of Utero-ovarian Transposition (UOT) for Fertility Preservation in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy (WPXRT)","UOT WPXRT","Inclusion Criteria:\n\n1. Age: Women 18 - 40 years of age who wish to preserve their fertility.\n2. Malignancy: Diagnosis of pelvic malignancies that require radiotherapy, including:\n\n   1. Colon and rectal cancer with tumors.\n   2. Anal cancer.\n   3. Other pelvic malignancies that require administration of WPXRT.\n3. Desire for Fertility Preservation: The patient expresses a clear desire to preserve fertility and the ability to carry a pregnancy in the future.\n4. Preoperative Ovarian Function: The patient must have normal ovarian function, demonstrated by specific hormonal values, including:\n\n   1. Follicle-Stimulating Hormone (FSH): \\\u003C10 IU\u002FL\n   2. Luteinizing Hormone (LH): within normal reference range for reproductive age (typically 1.5-8 IU\u002FL in the early follicular phase).\n   3. Anti-Müllerian Hormone (AMH): \\>1 ng\u002FmL\n   4. Estradiol (E2): within the normal range for the follicular phase (usually 30-120 pg\u002FmL).\n5. No Distant Metastasis: Absence of metastatic disease confirmed by imaging (CT, MRI, or PET scans).\n6. Body Mass Index (BMI) \\\u003C 35.\n7. Signed Informed Consent.\n\nExclusion Criteria:\n\n1. Advanced Cancer Stage: Patients with locally advanced or metastatic disease.\n2. Significant Uterine Pathology: Presence of large uterine fibroids, adenomyosis, or other intrauterine pathologies that would complicate the procedure or future pregnancy.\n3. Poor General Health or Comorbidities: Severe medical conditions that contraindicate surgical intervention, that include but not limited to:\n\n   * Cardiovascular Disease:\n\n     1. Recent (within 6 months) myocardial infarction (MI).\n     2. Ejection fraction (EF): EF \\\u003C30%.\n     3. Uncontrolled hypertension: Systolic BP \\>180 mmHg or Diastolic BP \\>110 mmHg prior to surgery.\n     4. Severe aortic stenosis: Valve area \\\u003C1 cm² with symptomatic status.\n   * Uncontrolled Diabetes Mellitus:\n\n     1. Hemoglobin A1c (HbA1c) \\> 9%\n     2. Persistent fasting glucose \\>250 mg\u002FdL preoperatively despite optimization.\n   * Severe Respiratory Diseases:\n\n     1. Forced expiratory volume (FEV1): \\\u003C50%.\n     2. Oxygen saturation: Resting SpO₂ \\\u003C88% on room air without supplemental oxygen.\n     3. CO2 retention: PaCO₂ \\>50 mmHg.\n   * Connective Tissue Disorders:\n\n     1. Severe systemic lupus erythematosus (SLE): Active lupus nephritis with GFR \\\u003C30 mL\u002Fmin.\n     2. Scleroderma with severe pulmonary hypertension or FVC \\\u003C50% predicted.\n     3. Rheumatoid arthritis with severe cervical spine instability (atlantoaxial subluxation).\n   * Severe Inflammatory Bowel Disease (IBD):\n\n     1. Severe Crohn's or ulcerative colitis flares with C-reactive protein (CRP) \\>10 mg\u002FL and hypoalbuminemia (Albumin \\\u003C2.5 g\u002FdL).\n     2. Severe malnutrition: BMI \\\u003C18.5 kg\u002Fm² or Prealbumin \\\u003C10 mg\u002FdL\n   * Steroid dependency:\n\n     1. Chronic steroid use (\\>20 mg prednisone daily) with no feasible taper pre-surgery.\n4. Prior Pelvic Radiotherapy.\n5. Prior history of systemic chemotherapy and immunotherapy that resulted in significant toxicity and residual deficit.\n6. Pregnancy: Patients who are currently pregnant are excluded from consideration for uterine transposition.\n7. Unsuitable for Ovarian Function Preservation: Women with signs of poor ovarian reserve, including:\n\n   * FSH: \\>10 IU\u002FL\n   * AMH: \\\u003C1 ng\u002FmL\n   * Estradiol: outside normal range.\n8. Non-Candidate for Fertility: Patients with contraindications to future pregnancy, such as severe uterine abnormalities or significant risk for pregnancy-related complications.\n9. Body Mass Index (BMI) ≥35.\n10. Absence of One of the Gonadal Vessels.\n11. Other unlisted conditions or diagnoses that, in the opinion of the primary investigator, render the patient an unsuitable candidate for uteroovarian transposition.","FEMALE","18 Months","40 Months",{"count":317,"type":20},26,[54],"This study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function.\n\nThe trial's primary objective is to assess the feasibility and safety of uterine and ovarian transposition (UOT). Premenopausal women under the age of 40 will undergo UOT using a novel minimally invasive approach.\n\nFeasibility and safety will be evaluated through standardized postoperative assessments, including:\n\n(A) success in mobilizing and repositioning the uterus, ovaries, and fallopian tubes while maintaining vascular integrity; (B) documentation of surgical complications; (C) monitoring the timeliness and adherence to planned WPXRT.\n\nTo enhance safety and optimize outcomes, intraoperative imaging with indocyanine green fluorescence and Doppler ultrasonography will be employed.\n\nShort-term success will be defined by technical success in repositioning the uterus and ovaries with preserved vascular integrity, absence of major surgical complications, and timely initiation and completion of WPXRT.\n\nLong-term success will be evaluated by the preservation of fertility.\n\nThe study's primary objective is also to evaluate surgical, reproductive, and quality-of-life outcomes following UOT. This objective will determine the procedure's efficacy in preserving ovarian and menstrual function and its potential to support future pregnancies.\n\nEndpoints include:\n\n(A) maintenance of normal premenopausal levels of FSH, LH, AMH, and estradiol at defined postoperative intervals; (B) assessment of menstrual timing, regularity, and characteristics to document return of ovulatory cycles; (C) evaluation of uterine integrity and reproductive potential using pelvic ultrasonography; (D) comprehensive evaluation of patient quality of life encompassing physical, emotional, sexual, and reproductive well-being.\n\nThese measures will inform optimization of surgical techniques and provide a foundation for scaling the procedure to a broader population in future studies.",[321,322,323],"Colorectal (Colon or Rectal) Cancer","Pelvic Malignancies","Oncofertility",[325,326,327,328,329,330,331,332],"uterine transposition","utero-ovarian transposition","oncofertility","pelvic radiation","pelvic malignancies","rectal cancer","colorectal malignancies","fertility preservation","2026-06-23",{"date":335,"type":33},"2026-06-24",{"date":337,"type":33},"2026-04-01",{"date":339,"type":20},"2031-06",{"name":39,"class":40},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":21,"phases":349,"briefSummary":350,"conditions":351,"keywords":355,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":41},"100620667","act-together-implementing-a-web-based-program-with-brief-coaching-for-parents-of-children-with-disabilities-in-pediatric-outpatient-clinics-100620667","NCT07360600","ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics","Inclusion Criteria (Parents of children with disabilities):\n\n1. Community-dwelling adults (aged ≥18 years) with primary caregiving responsibility for a child with disabilities (aged \\\u003C18 years) who is enrolled in a participating clinic;\n2. Expected to use services at the participating clinic at least once per week over the next three months;\n3. Willing to learn strategies to cope with emotions and thoughts; and\n4. Have access to a web-enabled device (e.g., smartphone, tablet, laptop, or desktop) with reliable internet access at home or in a public space (e.g., library).\n\nExclusion Criteria (Parents of children with disabilities):\n\n1. Cognitive, physical, sensory impairments, or language barriers (non-English speaking) that would impede participation;\n2. Suicidal intent or suicide attempt(s) within the past six months;\n3. Participation in another parent support research study at the time of recruitment; or\n4. More than three hospitalizations of either the parent or child within the past year, or other serious health concerns that would interfere with program engagement.\n\nInclusion Criteria (Occupational therapists):\n\n1. Be willing to participate in training, program implementation, and study evaluations; and\n2. Currently work in a pediatric clinic that serves at least 15 children who attend the clinic at least once per week.\n\nExclusion Criteria (Occupational therapists): N\u002FA",{"count":348,"type":20},60,[54],"The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them.\n\nThe main questions this study aims to answer are:\n\n* Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)?\n* Is the program usable and acceptable\u002Fappropriate\u002Ffeasible to implement in this setting?\n* Do parents show improvements in mental health and coping-related outcomes after participating in the program?\n* What are the experiences and perspectives of parents and therapists regarding the program?\n\nParents as participants will:\n\n* Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics.\n* Complete online questionnaires before starting and after completing the program.\n* Take part in one online interview about their experiences and perspectives on the program.\n\nOccupational therapists as participants will:\n\n* Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist.\n* Complete brief online questionnaires before starting and after delivering the program.\n* Take part in one online interview about their experiences and perspectives on the program.",[352,353,354,172],"Parents","Children With Disabilities","Stress",[356,183,357,358,359,360,180,361,181,362,182,363,184,185,364],"Acceptance and Commitment Therapy","internet-based intervention","occupational therapist","parents","children with disabilities","stress","acceptability","implementation","phone coaching","2026-06-22",{"date":333,"type":33},{"date":368,"type":33},"2026-03-18",{"date":370,"type":20},"2026-12",{"name":39,"class":40},{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":4,"eligibilityCriteria":378,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":21,"phases":381,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":41},"100643927","phase-1-a-prospective-open-label-study-evaluating-the-effectiveness-of-gepants-for-acute-treatment-of-migraine-in-the-emergency-department-100643927","NCT07667621","A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department","A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department","Inclusion Criteria:\n\n* • At least 18 years of age\n\n  * Capacity to provide informed consent (without a Representative)\n  * Emergency Department presentation for a headache consistent with migraine, based either on the treating clinical team's judgement, or fulfillment of International Classification of Headache Disorders (ICHD-3) criteria for migraine without aura or with typical aura, or for probable migraine without aura or with typical aura. It is acceptable if current headache duration is \\>72 hours. Must have been headache free for \\>48 hours prior to current attack.\n  * Willing to participate in post-discharge telephone assessments\n  * English and\u002For Spanish speaking patients\n\nExclusion Criteria:\n\n* • Use of intranasal decongestants within 1 hour prior to study drug administration, due to the potential to decrease absorption of intranasal zavegepant.\n\n  * Use of analgesics or abortive headache medications within 60 minutes of study medication administration\n  * Use of the following drug\u002Ffood categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors\u002Finducers, 5) NTCP transporter potent inhibitors\u002Finducers\n  * History of ischemic cardiovascular disease, diabetes, or hypertension (diagnosed or likely based on multiple readings), that was recently diagnosed within 3 months of screening or is currently uncontrolled or unstable\n  * History of any stroke within 3 months, or any lifetime stroke and age ≥65 years\n  * History of significant peripheral vascular disease, as assessed by the investigator or qualified delegate\n  * History of Raynaud's Phenomenon (medically diagnosed, or non-medically diagnosed with affirmative responses to both unusual sensitivity and finger color change with cold exposure)\n  * History of severe hepatic impairment, as assessed by the investigator or qualified delegate\n  * History of kidney disease stage 4 (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n  * History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients\n  * Lifetime use of CGRP-targeting acute or preventive migraine medications\n  * In custody of law enforcement\n  * Current pregnancy or lactation\n\n    * All individuals of childbearing potential must have a negative pregnancy test at screening (urine or serum).\n    * A person is considered to be of childbearing potential if possessing female reproductive organs at birth, post-menarchal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no cause identified other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).",{"count":380,"type":20},100,[382],"PHASE1","Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days. Participants will be allocated to either the rimegepant trial or the zavegepant trial. The study design does not include a placebo or active comparator control group, and the two gepant study drugs are not designed to function as active comparator groups. The objective in this investigation is to examine relief from either rimegepant or zavegepant in separate parallel trials.",[385,386,387,388,389,390,391],"Migraine","Migraine Disease","Migraine in Adults","Migraine Headache","Acute Migraine","Migraine Without Aura","Migraine With Aura","2026-06-20",{"date":394,"type":33},"2026-06-25",{"date":396,"type":20},"2026-07",{"date":398,"type":20},"2027-08",{"name":39,"class":40},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":16,"minAge":407,"maxAge":408,"enrollmentInfo":409,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":41},"100599950","digital-cognitive-behavioral-treatment-of-insomnia-in-youth-an-rct-examining-feasibility-acceptability-and-efficacy-of-nitecapp-jr-100599950","NCT07091149","Digital Cognitive Behavioral Treatment of Insomnia in Youth: An RCT Examining Feasibility, Acceptability, and Efficacy of NiteCAPP Jr","NiteCAPP JR","Inclusion Criteria:\n\nChild inclusion:\n\n1. 6-12 yrs\n2. Verbal IQ \\> 70 (to ensure verbal skills are sufficient to participate in treatment)\n3. participation of child's parent or legal guardian living in the same home\n4. child diagnosed with insomnia, 5) willing to accept random assignment.\n\nInsomnia:\n\n1\\) insomnia complaints for 3+ months by child report or caregiver observation that consist of (a) difficulties falling asleep, staying asleep, and\u002For waking up too early, (b) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, and (c) Pediatric Insomnia Severity Index score \\>8\n\nCaregiver inclusion:\n\n1. ability to read and understand English at the 5th grade level\n2. willing to accept random assignment.\n\nExclusion Criteria:\n\nChild exclusion:\n\n1. child unable to provide informed consent or child unable to provide assent\n2. child unwilling to accept random assignment\n3. child participation in another randomized research project\n4. child unable to complete forms or implement treatment procedures due to cognitive impairment\n5. child untreated medical comorbidity including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation\u002Fintent, \\[frequent\\] parasomnias)\n6. child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and\u002For melatonin as described in #7 (see Notes below for details)\n7. child stimulants, sleep medications (prescribed or OTC), and\u002For melatonin within the last 1 month (unless stabilized on medication for 3+ months)\n8. child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n9. child other conditions adversely affecting trial participation.\n\nCaregiver exclusion criteria:\n\n1. unable to provide informed consent\n2. unwilling to accept random assignment\n3. caregiver participation in another randomized research project\n4. unable to complete forms or implement treatment procedures due to cognitive impairment\n5. caregiver participation in non-pharmacological treatment (including CBT) for sleep outside current trial","6 Years","12 Years",{"count":116,"type":20},[54],"The proposed pilot will examine feasibility, acceptability, and preliminary efficacy of a digital CBT-I tailored for school-aged children.",[413],"Insomnia",[415,416,417,418],"dCBTi","digital intervention","insomnia","children","2026-06-11",{"date":421,"type":33},"2026-06-15",{"date":423,"type":33},"2025-04-10",{"date":425,"type":20},"2027-05-01",{"name":39,"class":40},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":432,"eligibilityCriteria":433,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":434,"targetDuration":4,"studyType":21,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":448,"locationsCount":41},"100411062","web-based-cognitive-behavioral-treatment-for-insomnia-in-dementia-caregivers-100411062","NCT04632628","Web-based Cognitive Behavioral Treatment for Insomnia in Dementia Caregivers","NiteCAPP","CAREGIVER\n\nInclusion Criteria:\n\n* 18+ yrs\n* Dementia caregiver living with person with dementia\n* willing to be randomized, 4. read\u002Funderstand English\n* insomnia diagnosis\n* no prescribed or over-the-counter sleep meds or stabilized 6+ weeks.\n\nInsomnia:\n\n* complaints for 6+ mos\n* adequate opportunity and circumstances for sleep\n* 1+ of the following: difficulty falling asleep, staying asleep, or waking too early\n* daytime dysfunction (mood, cognitive, social, occupational) due to insomnia\n* Screening interview indicates Insomnia Severity Index score ≥11 or Insomnia Severity Index score 9-10\n* baseline diaries indicate \\>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.\n\nExclusion Criteria:\n\n* unable to consent\n* cognitive impairment \\[Telephone Interview for Cognitive Status (TICS) \\\u003C25 or Mini Mental State Examination (MMSE) \\\u003C26\\]\n* sleep disorder other than insomnia \\[i.e., sleep apnea (apnea\u002Fhypopnea index, AHI \\>15)\\]\n* bipolar or seizure disorder\n* other major psychopathology except depression or anxiety (e.g., suicidal ideation\u002Fintent, psychosis)\n* severe untreated psychiatric comorbidity\n* psychotropic or other medications (e.g., beta-blockers) that alter sleep\n* non-pharmacological tx for sleep or mood outside current trial.\n\nPERSONS WITH DEMENTIA\n\nInclusion Criteria:\n\n* 18+ yrs\n* Persons with dementia living with caregiver\n* Have an eligible caregiver\n* willing to be randomized\n\nExclusion Criteria:\n\n• Person with dementia or legally authorized representative is unable to consent",{"count":348,"type":20},[54],"Over the next 30 years, more than 10 million persons living with dementia in the United States will receive care at home from an unpaid and untrained family caregiver. At home care is preferred by caregivers and persons with dementia alike, but increases the caregiver's risk of insomnia and related negative health outcomes, including depression, anxiety, cognitive disturbances and poor quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is a highly effective and established evidence based treatment for adults of all ages. Although relatively understudied in dementia caregivers, the research by our group and others suggests CBT-I is also efficacious in caregivers. Our team developed a brief (4 session) CBT-I protocol specifically adapted for dementia caregivers (CBT-I) and has shown in person and remote (i.e. telehealth) delivery of this protocol significantly reduces insomnia symptoms and improves mood (moderate to large effects). Given demands on caregivers' time and limited availability of trained CBT-I providers, a web-based version of CBT-I (WebCBT-I; the online treatment will be called NiteCAPP) is needed to increase the accessibility of this efficacious treatment. WebCBT-I will allow for flexible at home scheduling, and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers. The overarching goal of this project is to develop and test WebCBT-I in caregivers of persons with dementia.\n\nObjectives\n\n1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in dementia caregivers with insomnia.\n2. To examine changes in the primary clinical outcomes, including complaints of poor sleep, and fatigue.\n3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.\n4. To examine the mechanistic variables, including arousal (heart rate variability, HRV).",[438,174],"Insomnia Chronic",[440,441,442,443,413,174],"Dementia Caregiver","Sleep","Behavioral Interventions","Online Behavioral Intervention",{"date":421,"type":33},{"date":446,"type":33},"2023-11-14",{"date":105,"type":20},{"name":39,"class":40},{"id":450,"slug":451,"hasResults":12,"nctId":452,"briefTitle":453,"officialTitle":454,"acronym":4,"eligibilityCriteria":455,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":201,"enrollmentInfo":456,"targetDuration":4,"studyType":21,"phases":458,"briefSummary":459,"conditions":460,"keywords":462,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":41},"100638061","dry-needling-in-multiple-sclerosis-100638061","NCT07615725","Dry Needling in Multiple Sclerosis","Non-pharmacological Management of Chronic Pain in Persons With Multiple Sclerosis","Inclusion Criteria: Diagnosis of Multiple Sclerosis based on McDonald's Criteria; Patient Determined Disease Steps (PDDS) score of 1-5 (ambulatory participants), the ability to communicate written and spoken English, , age 18-80 and experiencing pain in the lower extremity for more than three consecutive months (3-months) with intensity of 3 or more out of 10 based on numeric pain scale (clinically meaningful pain).\n\nExclusion Criteria: any neurological comorbidity (such as stroke and PD), presence of MS relapse in the last 30 days, current participation in or planned initiation of any pain management intervention (interventional or rehabilitative) targeting the lower extremity, or anticipated changes in pain medication during the study period. Additional exclusion criteria include pregnancy (by urine pregnancy test), any active cancer or chemotherapy within one year, the score of lower than 17 on the MoCA (Montreal Cognitive Assessment), a known or suspected infection in the lower extremity, deep vein thrombosis, thrombophlebitis, active osteomyelitis in the lower extremity, varicose veins and uncontrolled seizures\u002F epilepsy.",{"count":457,"type":20},24,[54],"This study is placed at the Human Functional Performance Laboratory in the School of physical therapy and Rehabilitation Sciences (MDT building) at University of South Florida. The study is supported by Consortium of Multiple Sclerosis Centers. We are doing this study to see if a treatment called dry needling improves chronic pain in the lower limb (from the low back to the foot) in people who have Multiple Sclerosis. Dry needling involves using tiny needles, like those used in acupuncture, to target certain muscles, such as the thigh or calf muscles. It is different from traditional acupuncture because it focuses on treating specific muscle spots to reduce muscle stiffness and pain. Dry needling may help reduce your pain without any medication. We also hope to see whether dry needling helps improve balance and walking abilities, which may lead to better day-to-day functioning. In this study, there are two groups. In each group, participants will receive six sessions of dry needling. One group will receive actual dry needling, while the other group will receive a procedure that mimics dry needling. The treatment you get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what treatment you get. You will have an equal chance of being given either treatment or sham treatment. You will not be told which treatment you are getting; however your study doctor will know. You are being asked to take part because you have been diagnosed with Multiple Sclerosis and are experiencing long-lasting pain in your lower limbs, including the buttocks, thighs, calf, and foot. We want to find out if this treatment will help people with Multiple Sclerosis who have lower limb pain.",[461],"Multiple Sclerosis",[463],"Pain","2026-05-22",{"date":466,"type":33},"2026-05-29",{"date":468,"type":33},"2026-05-08",{"date":470,"type":20},"2027-06-01",{"name":39,"class":40},{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":16,"minAge":479,"maxAge":4,"enrollmentInfo":480,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":482,"conditions":483,"keywords":485,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":41},"100386266","diagnostic-accuracy-of-shuntcheck-compared-to-radionuclide-shunt-patency-in-patients-with-normal-pressure-hydrocephalus-100386266","NCT04309487","Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus","Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study","Inclusion Criteria:\n\n* Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.\n* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as \"surrogates\" in this protocol) capable of providing valid, signed informed consent\n\nExclusion Criteria:\n\n* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;\n* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;\n* Presence of an interfering open wound or edema over any portion of the VP shunt.","40 Years",{"count":481,"type":20},20,"The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.",[484],"Hydrocephalus, Normal Pressure",[486,487],"Asymptomatic Normal Pressure Hydrocephalus","Ventriculoperitoneal Shunt","2026-05-14",{"date":490,"type":33},"2026-05-18",{"date":492,"type":33},"2020-01-24",{"date":494,"type":20},"2027-01",{"name":39,"class":40},{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":16,"minAge":479,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":41},"100363388","assessment-of-shuntcheck-performance-characteristics-in-asymptomatic-patients-with-normal-pressure-hydrocephalus-100363388","NCT04011566","Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus","Inclusion Criteria:\n\n* Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.\n* Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent.\n\nExclusion Criteria:\n\n* Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;\n* ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;\n* Presence of an interfering open wound or edema over any portion of the ventriculoperitoneal shunt.",{"count":19,"type":20},"The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.",[484],[486,487],{"date":507,"type":33},"2026-05-19",{"date":509,"type":33},"2019-06-11",{"date":511,"type":20},"2026-11",{"name":39,"class":40},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":527,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":541,"locationsCount":41},"100611490","hydrate-heroes-for-improving-brain-function--mood-100611490","NCT07241260","Hydrate Heroes for Improving Brain Function & Mood","Boosting Brain and Mood: Exploring the Impact of Hydrate Heroes on Mental Health and Brain Activity","Inclusion Criteria:\n\n* Age between 18 and 65 years at time of consent.\n* Fluent in English (able to read, write, speak, and understand English).\n* Generally healthy, without chronic medical conditions (see Exclusion 10.3).\n* Willing and able to attend three in-person study visits over an approximate 12-week period (enrollment, \\~6 weeks, \\~12 weeks).\n* Willing to consume assigned Hydrate Heroes packets as directed (6 sticks\u002Fday, 3 sticks\u002Fday, or no supplement for control).\n* Willing to log daily water intake and number of Hydrate Heroes packets consumed in the study's online tracking system.\n* Capable of providing informed consent.\n\nExclusion Criteria:\n\n* Neurological or Psychiatric Conditions\n* History of epilepsy, recurrent seizures, severe head injury, or other significant neurological disorders.\n* Current diagnosis of major psychiatric disorders (e.g., schizophrenia, bipolar disorder, severe major depressive disorder).\n\n  · Cardiovascular or Renal Conditions\n* Chronic kidney disease, congestive heart failure, or any condition requiring medically supervised fluid restriction.\n* Documented electrolyte imbalance (e.g., hyponatremia, hypokalemia) within the past 6 months.\n* Medication and Supplement Conflicts\n* Use of medications known to alter EEG readings (e.g., benzodiazepines, antiepileptics, antipsychotics).\n* Use of high-dose diuretics or other drugs that substantially affect hydration status.\n* Concurrent use of any supplements containing one or more key ingredients of Hydrate Heroes - adaptogenic mushroom blends, magnesium, potassium, zinc, vitamin D₃, vitamin C (including Amla), electrolytes, or elderberry - that cannot be safely discontinued for the 12-week study duration.\n* Reproductive Status\n* Pregnant or currently breastfeeding.\n* Compliance Risk\n* Inability or unwillingness to reliably follow the hydration\u002Fsupplement protocol or complete daily logging.\n* Inability to attend scheduled visits or follow instructions.","65 Years",{"count":522,"type":20},48,[54],"The primary goal of this 12-week randomized controlled study is to evaluate whether daily use of Hydrate Heroes results in measurable improvements in brain activity, mental health, and performance on cognitive tasks. By analyzing brainwave data, physical response metrics, and patient-reported outcomes, the study will demonstrate whether the supplement produces meaningful effects on mental and neurological health.",[526],"Hydration Status",[528,529,66,530,531,532,533,534,535],"hydration","electroencephalography","brain activity","electrolytes","mental health","supplement","depression","anxiety","2026-04-29",{"date":538,"type":33},"2026-04-30",{"date":132,"type":20},{"date":37,"type":20},{"name":39,"class":40},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":313,"minAge":17,"maxAge":285,"enrollmentInfo":549,"targetDuration":4,"studyType":21,"phases":551,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":225},"100602706","ilr-to-prevent-brclmcc-23608-100602706","NCT07127003","ILR to Prevent BRCL_MCC 23608","Prospective, Randomized Clinical Trial for Immediate Lymphatic Reconstruction to Prevent Breast Cancer Related Lymphedema","Inclusion Criteria:\n\n* Patients consenting for unilateral ALND \\[prior history of sentinel lymph node biopsy (SLNBx) allowed if \\\u003C6 months from consent\\]\n* Patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon\n* Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery\n* Female breast cancer patients 18-75 years of age (inclusive)\n\nExclusion Criteria:\n\n* • Male breast cancer patients\n\n  * Non-English speaking participants\n  * Female breast cancer patients with axillary recurrence\n  * Female breast cancer patients who have a history of ALND\n  * Female patients requiring bilateral ALND for the treatment of their breast cancer\n  * Female breast patients treated with SLNBx only\n  * Primary lymphedema of the affected upper limb\n  * Secondary lymphedema of the affected limb prior to the lymphadenectomy\n  * Radiotherapy at the axilla before the study \u002F surgery\n  * Life expectancy \\\u003C 2 years for any reason\n  * Pregnancy or nursing\n  * Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening\n  * Severe psychiatric disease\n  * Distant metastases at the time of preoperative screening",{"count":550,"type":20},98,[54],"The goal of this clinical trial is to evaluate the effectiveness of Immediate Lymphatic Reconstruction (ILR) in preventing breast cancer-related lymphedema (BCRL) in high-risk patients. It will also assess the safety and quality of life outcomes associated with the procedure. The main questions it aims to answer are:\n\nDoes ILR reduce the incidence of BCRL in patients undergoing axillary lymph node dissection (ALND)?\n\nWhat are the patient-reported outcomes and quality of life differences between those who receive ILR and those who do not?\n\nParticipants will be identified as high-risk for developing BCRL through a multidisciplinary tumor board and referred to a specialized clinic for further evaluation. High-risk patients will undergo a series of screening tests, including bioimpedance spectroscopy (BIS), circumferential limb measurements, and infrared 3D perometry.\n\nParticipants will be randomly assigned to one of two groups:\n\nIntervention Group (Study Arm A): Undergo ILR during ALND surgery, where preserved lymphatic channels are connected to nearby veins to prevent lymphedema.\n\nControl Group (Study Arm B): Will not receive ILR, but efforts will be made to preserve lymphatic channels during surgery.\n\nPatients will be blinded to their group assignment. Post-surgery, all participants will receive education from a certified lymphatic physical therapist.\n\nAt the 2-week postoperative visit, participants will be further randomized into two postoperative monitoring protocols:\n\nBCRL Clinical Pathway: Patients will have regular follow-up visits every three months for two years, including repeat BIS, limb measurements, perometry, and quality of life questionnaires (LYMQOL and ULL-27).\n\nStandard of Care: Patients will be monitored only if they experience BCRL symptoms or after two years from ALND.\n\nThe study will compare the outcomes of both groups, with a focus on the incidence of BCRL and patient quality of life, and will benchmark these results against published literature on breast cancer patients.",[554],"Breast Cancer Lymphedema",[556,557,558],"Axillary lymph node dissection","breast cancer","lymphedema",{"date":538,"type":33},{"date":561,"type":33},"2025-10-01",{"date":563,"type":20},"2027-10-01",{"name":39,"class":40},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":49,"sex":16,"minAge":573,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":21,"phases":576,"briefSummary":577,"conditions":578,"keywords":585,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":136},"100571599","palliative-care-education-in-assisted-living-for-dementia-care-providers-pceal-dcp-100571599","NCT06722352","Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)","Preparing Assisted Living Staff to Provider Palliative Care to Residents With Dementia: Palliative Care Education in Assisted Living for Dementia Care Providers (PCEAL-DCP)","PCEAL-DCP","Inclusion Criteria:\n\nThe AL community eligibility criteria include a minimum of 40+ beds and provide memory care services to at least 35% of their residents, and access to hospice services from Lifepath or Suncoast Hospice. The AL size of 40+ beds is selected so we will be able to recruit a minimum of 14 residents per site, based on the power analysis for the sample size of 450 for the primary study outcome of documentation of ACP discussions.\n\nResidents are eligible if 1) they have a dementia diagnosis confirmed by the resident's physician (physician's signature required by University of South Florida (USF) Institutional Reiew Board (IRB) in prior clinical trial) regardless of dementia severity (mild, moderate, or severe), 2) if they have been admitted to the AL in the last month, and 3) if they have a legally responsible representative who understands English.\n\nStaff are eligible if they are currently employed with the participating study AL as a registered\u002Flicensed practical nurse, administrator, or dementia care coordinator of a memory care unit and English speaking and 21 years of age or older.\n\nFamily members are eligible if 1) they are listed as the legally responsible party in the chart records for the resident with ADRD, 2) they understand English, and 3) are at least 21 years of age or older. This could include someone related to the person, a close friend or a legal guardian who oversees the person's care and is responsible for decisions about their care.\n\nExclusion Criteria:\n\nAL sites will be ineligible if 1) the are not a licensed Florida assisted living facility; 2) they have previously participated in a PCEAL-DCP clinical trial (2018-2021) to avoid possible experimental contamination effects, and 3) if no staff employed at the AL are willing to participate in the study.\n\nResidents are ineligible if they: 1) are currently receiving hospice services because residents who receive hospice are already engaged in ACP discussions upon admission; 2) if they are discharged from assisted living to another setting (nursing home or hospital) or are admitted to hospice or have died before baseline data is collected.\n\nStaff will be ineligible if they are not licensed nurses, administrators or dementia care coordinators of a dementia care unit or terminated\u002Fresign before baseline data is collected.\n\nFamily are ineligible if: 1) they are under 21 years of age and do not understand spoken or written English and if there is already a legal authorized representative for a resident participating in the study (one family member per resident).\n\n\\-","21 Years",{"count":575,"type":20},792,[54],"The palliative care education in assisted living for dementia care providers (PCEAL-DCP) is a 4-week intervention (once a week for 1.5 hours, a total of 6 hours) for licensed nurses, administrators and dementia care coordinators to improve quality of dementia care outcomes",[579,580,581,582,583,584],"Alzheimer Disease","End of Life","Caregiver Burden","Caregiver Burnout","Patient Participation","Self Efficacy",[586,587,588,589,590,179,591,592],"end of life","palliative care","education","staff training","assisted living","dementia care","Alzheimer's","2026-04-27",{"date":536,"type":33},{"date":596,"type":33},"2025-01-28",{"date":598,"type":20},"2029-08-01",{"name":39,"class":40},{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":432,"eligibilityCriteria":606,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":607,"targetDuration":4,"studyType":21,"phases":608,"briefSummary":609,"conditions":610,"keywords":611,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":612,"lastUpdatePostDateStruct":613,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":617,"locationsCount":41},"100431337","nitecapp-web-based-interventions-for-insomnia-in-rural-dementia-caregivers-100431337","NCT04896775","NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers","NiteCAPP: Web-based Interventions for Insomnia in Rural Dementia Caregivers: Examination of Sleep, Arousal, Mood, Cognitive, and Immune Outcomes","Inclusion:\n\nCaregiver Eligibility. Inclusion criteria: 1. 18+ yrs, 2. CG living with PWD, 3. willing to be randomized, 4. read\u002Funderstand English, 5. insomnia diagnosis, 6. no prescribed or over the counter sleep meds for 1+ mo, or stabilized 6+ mos.\n\n* Insomnia: 1. complaints for 6+ mos, 2. adequate opportunity and circumstances for sleep, 3. 1+ of the following: difficulty falling asleep, staying asleep or waking too early, 4. daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, 5. baseline diaries indicate \\>30 mins of sleep onset latency or wake after sleep onset on 3+ nts.\n\nPWD Eligibility. 1. probable\u002Fpossible Alzheimer's Disease (self-report or primary care provider written confirm), 2. 1+ problem on Nighttime Behavior Inv. 3+ nts\u002Fwk, 3. tolerate actigraphy, 4. no sleep meds 1+ mo or stabilized 6+ mos, 5. untreated sleep disorder for which CBT-I is not recommended (e.g., apnea), 6. scoring \\\u003C32 on Sleep Apnea scale, Sleep Disorders Ques.\n\nExclusion:\n\nCG Exclusion criteria: 1. unable to consent, 2. cognitive impairment \\[Telephone Interview for Cognitive Status (TICS) \\\u003C25\\], 3. sleep disorder other than insomnia \\[i.e., apnea (apnea\u002Fhypopnea index-AHI \\>15)\\], 4. bipolar or seizure disorder, 5. other major psychopathology except depression or anxiety (e.g., suicidal, psychotic), 6. severe untreated psychiatric comorbidity, 7. psychotropic or other medications (e.g., beta-blockers) that alter sleep, 8. non-pharmacological tx for sleep or mood outside current trial.",{"count":380,"type":20},[54],"The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample (n of 100 caregiver and PWD dyads). We will measure both the short term (post-treatment) and long term (6 and 12 months) effects of the intervention on CG sleep, arousal, inflammation, health, mood, burden and cognitive function, and PWD sleep.",[413,174],[440],"2026-04-24",{"date":538,"type":33},{"date":615,"type":33},"2022-02-02",{"date":105,"type":20},{"name":39,"class":40},{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":21,"phases":627,"briefSummary":628,"conditions":629,"keywords":631,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":639,"completionDateStruct":641,"leadSponsor":643,"locationsCount":41},"100635910","a-randomized-controlled-efficacy-trial-of-a-telemedicine-based-virtual-reality-clinic-for-the-treatment-of-phobias-100635910","NCT07558824","A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias","Doxy.me VR vs. Telemental Health-Based Exposure Therapy: Phase II","Inclusion Criteria:\n\nIndividuals will be eligible if they: (1) are an adult (≥18 years old); (2) have a self-reported fear of dogs, snakes, and\u002For spiders; (3) score 89 ≥ on the FSQ OR 24 ≥ on the SNAQ OR 147 ≥ on the DPQ; and (4) have access to the internet AND a computer OR smartphone with video conferencing capabilities.\n\nExclusion Criteria:\n\nIndividuals will be ineligible to participate if they: (1) are participating in ongoing mental health therapy from a non-study therapist; (2) changed psychiatric medication use within the past 6 weeks; (3) report active auditory, visual, and\u002For tactile hallucinations via the DART Psychosis Module screening question; (4) report active health conditions requiring upcoming planned or likely hospitalization or intensive treatment that will prevent them from participating; (5) report active legal proceedings that might lead to incarceration during the study period that would prevent them from participating; (6) report an unstable housing situation (eg., eviction or homelessness); (7) have experienced photosensitive seizures within the prior 6 months; (8) endorse more than 20% of symptom validity questions.",{"count":626,"type":20},240,[54],"The goal of this clinical trial is to learn if a telemedicine-based virtual reality clinic (Doxy.me VR) works to treat dog, spider, and snake phobias in adults. The main questions it aims to answer are:\n\nDoes Doxy.me VR decrease the severity of phobias better than traditional telemedicine-based treatment? Does this work because it feels more realistic than telemedicine alone?",[630],"Specific Phobia, Animal",[632,633,634,635,636],"phobia","phobias","snakes","dogs","spiders","2026-04-23",{"date":538,"type":33},{"date":640,"type":20},"2026-04",{"date":642,"type":20},"2028-01",{"name":39,"class":40},{"id":645,"slug":646,"hasResults":12,"nctId":647,"briefTitle":648,"officialTitle":649,"acronym":4,"eligibilityCriteria":650,"healthyVolunteers":49,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":651,"targetDuration":4,"studyType":21,"phases":653,"briefSummary":654,"conditions":655,"keywords":659,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":671,"locationsCount":41},"100542669","improving-sleep-and-reducing-opioid-use-in-individuals-with-chronic-pain-100542669","NCT06345872","Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain","SPIN Opioid: Improving Sleep and Reducing Opioid Use in Individuals With Chronic Pain","Inclusion Criteria:\n\n* 18+ yrs\n* willing to be randomized,\n* can read\u002Funderstand English\n* diagnosed with chronic widespread pain and insomnia (as described below)\n* prescribed opioid medication for 1+ mo, 3+ times per week\n* desire to reduce or eliminate opioid use\n* written agreement from physician prescribing opioid medication\n* no prescribed or OTC sleep meds for 1+ mo, or stabilized on meds for 6+ wks\n\nExclusion Criteria:\n\n* unable to provide informed consent\n* cognitive impairment (MMSE \\\u003C26)\n* sleep disorder other than insomnia \\[i.e., sleep apnea (apnea\u002Fhypopnea index, AHI \\>15)\n* Periodic Limb Movement Disorder (myoclonus arousals per hour \\>15)\\]\n* bipolar or seizure disorder (due to risk of sleep restriction treatment)\n* other severe, untreated major psychopathology except for depression or anxiety (e.g.,suicidal ideation\u002Fintent, psychotic disorders)\n* psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep (medications prescribed for pain or sleep are allowed)\n* participation in other non-pharmacological treatment for pain, sleep, or mood outside the current trial\n* internal metal objects or electrical devices\n* pregnancy\n* presumptive\u002Fconfirmed lumbar nerve root compression\n* confirmed lumbar spinal stenosis\n* \\\u003C6 mos post-back surgery\n* other spinal disorders",{"count":652,"type":20},165,[54],"The goal of this study is to test two behavioral interventions for chronic insomnia in individuals with chronic pain and use prescribed opioid medication to treat their chronic pain.",[656,657,658],"Chronic Pain","Chronic Insomnia","Opioid Use",[660,661,662,663],"Chronic pain","Chronic insomnia","Opioid use","CBT-I","2026-04-17",{"date":666,"type":33},"2026-04-21",{"date":668,"type":33},"2024-12-11",{"date":670,"type":20},"2028-07-01",{"name":39,"class":40},{"id":673,"slug":674,"hasResults":12,"nctId":675,"briefTitle":676,"officialTitle":676,"acronym":677,"eligibilityCriteria":678,"healthyVolunteers":12,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":679,"targetDuration":4,"studyType":21,"phases":680,"briefSummary":681,"conditions":682,"keywords":686,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":690,"lastUpdatePostDateStruct":691,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":136},"100579832","mirror-speech-entrainment-a-novel-technique-for-voice-personalized-speech-entrainment-for-nonfluent-aphasia-100579832","NCT06829420","Mirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia","MSE","Inclusion Criteria:\n\n* Adults between the ages of 18-70 years old\n* Dominant English-speaking\n* Aphasia due to left hemisphere stroke\n\nExclusion Criteria:\n\n* Individuals with aphasia due to other causes such as dementia, Alzheimer's disease and Parkinsonism\n* Non-dominant English adult speakers\n* Persons with significant difficulties with language comprehension\n* Persons with concomitant cognitive disability\n* Persons with uncorrected sensory deficits.",{"count":481,"type":20},[54],"The goal of this clinical trial is to test the use of voice personalization through artificial intelligence (AI) voice cloning on speech entrainment tasks to improve language production of persons with aphasia (PWA). The main question the study aims to answer is:\n\n\\- What is the impact of personalized voice on speech entrainment in PWA compared to traditional speech entrainment?\n\nSpeech entrainment is a technique used by speech-language pathologists to improve the speech production of PWA. Traditionally, speech therapists act as the model for participants to speak along with to improve their speech production. This study proposes the use of one's own voice (digitally altered) to improve speech production.\n\nThe study uses a mobile health approach to administer speech entrainment treatment through a mobile app.\n\n* Smartphones with the mobile app pre-installed will be mailed to participants at no cost.\n* Participants will complete treatment in the comfort of their homes.\n* The experimental treatments involve: mirror speech entrainment (speaking along to one's own voice) and traditional speech entrainment (speaking along to someone else's voice).",[683,684,685],"Aphasia Non Fluent","Stroke","Aphasia",[685,687,688,689],"Nonfluent aphasia","Speech entrainment","Speech synchronization","2026-04-15",{"date":666,"type":33},{"date":693,"type":33},"2025-05-01",{"date":695,"type":20},"2027-08-01",{"name":39,"class":40},""]