[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-impairment-sensorineural\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-impairment-sensorineural":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100636951","clinical-evaluation-of-the-rh210-hearing-aid-100636951",false,"NCT07572357","Clinical Evaluation of the RH210 Hearing Aid","Clinical Evaluation of the RH210 Hearing Aid Software Used With RH210A Device in Adults With Perceived Mild-to-Moderate Hearing Loss","Inclusion Criteria:\n\n* Age 18 years\n* Self-perceived mild-to-moderate hearing difficulties\u002F hearing loss\n* Competent smartphone use (able to complete self-fitting via the app)\n* Able and willing to provide informed consent\n* HHIA screening consistent with perceived hearing difficulty\n* Willingness and ability to attend two in-person research appointments\n* Ability to operate a SmartPhone\n\nExclusion Criteria:\n\n* Conductive or mixed hearing loss\n* Occluding cerumen\n* Otologic disease\u002F active ear pathology\n* Severe or profound hearing loss (PTA \\>S0dBHL) (WHO, 2021)\n* Presence of (red-flag) conditions relevant to OTC hearing aid use (per 21 CFR 801.421)\n* Visible deformity of the ear (congenital or traumatic).\n* Fluid, pus, or blood coming from the ear (e.g., active drainage).\n* Sudden or rapidly progressive hearing loss within the recent past (often defined as within \\~90 days).\n* Any acute or chronic dizziness or vertigo associated with hearing issues.\n* Pain or discomfort in or around the ear.\n* Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.\n* Unilateral hearing loss of sudden onset or large asymmetry between ears.\n* Audiometric air-bone gap suggestive of possible conductive pathology (e.g., gap equal or more than 15 dB at key frequencies)\n* Visible evidence of significant cerumen (ear wax) accumulation or foreign body in the ear canal.\n* Unilateral hearing loss of sudden onset or large asymmetry between ears","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"NA","The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss. The purpose of this clinical investigation is to generate objective and subjective evidence of the clinical performance and safety of the device.",[26,27],"Hearing Impairment, Sensorineural","Perceived Hearing Loss","RECRUITING","2026-05-26",{"date":31,"type":32},"2026-05-29","ACTUAL",{"date":34,"type":32},"2026-04-11",{"date":36,"type":20},"2026-08-30",{"name":38,"class":39},"Rehear Audiology Company LTD","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":56,"conditions":57,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":40},"100616316","phase-1-a-treatment-for-a-form-of-age-related-central-auditory-processing-disorder-consisting-of-clemastine-fumarate-plus-engineered-sound-100616316","NCT07304024","A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound","A Double-Blinded, Placebo-Controlled, Randomized, Phase 1\u002F2a Clinical Study to Test the Safety and Efficacy of a Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound","CAPD-LOOT","Inclusion Criteria:\n\n* Male or female between 45 and 65 years old (middle aged) at the screening\u002Fenrollment visit (Visit 1).\n* Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.\n* Documentation of no more than a mild high-frequency hearing sensitivity loss and normal middle-ear function will be obtained using standard audiometric equipment with measurements done by an audiologist; Specifically, testing will show:\n\n  * bilateral hearing thresholds \\\u003C 20 dB HL at audiometric frequencies from 250 Hz to 4000 Hz inclusively, with no air-bone gaps \\> 10 dB.\n  * symmetrical hearing thresholds between the ears through 8000 Hz, defined as \\\u003C20 dB difference at any single audiometric frequency or \\\u003C 15 dB difference at 2 or more contiguous frequencies.\n  * normal (Type A) tympanograms bilaterally.\n* No cognitive deficit shown upon screening with the Montreal Cognitive Assessment (MOCA) test (Nasreddine et al. 2005).\n* Distortion product otoacoustic emission (DPOAE) showing no more than 20 dB hearing loss at audiometric frequencies from 250 Hz to 4000 Hz.\n* Subjects failing the hearing in noise test at 15 degrees. Failing is defined as SNR being 12 dB below from what is found in normal hearing subjects without central hearing loss.\n\nExclusion Criteria:\n\n* Any subjects who do not fall under the criteria defined above.\n* Any of the following conditions which are listed as contraindications or warnings for use of the clinical trial drug (from labeling):\n\n  * Known sensitivity to clemastine fumarate or other antihistamines of similar composition\n  * Pregnancy or nursing mother as determined objectively with a urine pregnancy test\n  * Lower respiratory tract disease including asthma, or breathing difficulties such as emphysema or chronic bronchitis\n  * Glaucoma or increased intraocular pressure\n  * Stenosing peptic ulcers or pyloroduodenal obstruction\n  * Trouble urinating due to an enlarged prostate gland. Mild urinary issues (Stage 1 Benign Prostatic Hyperplasia) will not be considered an automatic exclusion but it must be emphasized to patients with this diagnosis that difficulty urinating is a possible side effect that may compound their BPH symptoms.\n  * Significant cardiovascular disease, chronic hypertension or hypotension\n  * Hyperthyroidism\n  * Alcoholism- as defined by consuming on average 3+ drinks per day for women or 4+ drinks per day for men or previous diagnosis of alcohol use disorder by a clinician as defined by DSM V criteria.\n  * Patients with a history of seizures will be excluded.\n  * Patients with evidence of suicidal ideation\u002Fbehavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).\n* We will generally exclude subjects with significant or uncontrolled medical disorders (e.g., hepatic, hematologic, renal, gastrointestinal, neurological, psychiatric disorders). We will define these patients as those who fall outside of normal ranges for a physical examination of vital signs, a 12-lead EKG, and a safety clinical laboratory assessment including complete blood count (CBC) and comprehensive metabolic panel (CMP). Exclusion with these tests will specifically focus on identifying the following disorders based on the listed criteria:\n* Leukopenia as defined as a CBC white blood cell count \\\u003C 4000\u002Ful\n* Anemia as defined by a CBC Hemoglobin \\\u003C9.0 g\u002FdL or \\\u003C10.0 g\u002FdL (Grade 2+ CTCAE)\n* Lymphopenia as defined by CBC Absolute lymphocyte count \\\u003C1000\u002FµL.\n* Neutropenia as defined by CBC ANC \\\u003C1500\u002FµL (solid tumors), ANC \\\u003C1000\u002FµL (hematologic malignancies). In the case of participants with African, Middle Eastern or West Indian descent a clinician's judgement will be considered to assess the possibility of benign ethnic neutropenia which is not an exclusion criteria.\n* Thrombocytopenia as defined by CBC Platelet count \\\u003C75000\u002FµL\n* Hepatic Impairment based on CMP: Total bilirubin \\>1.5× ULN, AST\u002FALT \\>3× ULN (or \\>5× ULN if liver metastases), Alkaline phosphatase \\>3× ULN.\n* Hepatic Impairment based on CMP: Serum creatinine \\>2.0 mg\u002FdL (alternative threshold).\n* Metabolic abnormalities based on CMP: Albumin \\\u003C3.0 g\u002FdL\n* Taking medications that would contraindicate taking the clinical trial drug; Specifically, (from labeling):\n\n  * Monoamine oxidase inhibitor therapy\n  * CNS depressants (sedatives, tranquilizers, hypnotics)\n* A history of significant otologic disorder such as repetitive ear infections or Meniere's disease\n* A history of significant neurologic disorder, or current neurodegenerative diseases such as multiple sclerosis, which could present a confound and impact the electrophysiological outcome measures.\n* A history of traumatic brain or closed head injury because this can cause symptoms of central auditory processing problems unrelated to aging and demyelination.\n* English as a second language (non-native English speakers), which is known to negatively impact scores on speech recognition testing.\n* Presence of any other condition or abnormality that in the opinion of the Investigator or his co-PIs would compromise the safety of the patient or the quality of the data.","45 Years","65 Years",{"count":52,"type":20},344,[54,55],"PHASE1","PHASE2","The goal of this clinical trial is to determine the efficacy of Clemastine Fumarate in the presence of engineered sound to treat age-related central auditory processing disorder (CAPD). This disorder impacts 800M patients worldwide, including \\~1\u002F3 people over 40 years of age and \\~1\u002F2 people over 65, resulting in an inability to hear in noisy environments.\n\nThe primary hypothesis this study aims to test is: engineered sound, driving localized neural circuit activity, will enable Clemastine Fumarate to mature Oligodendrocyte cells and thus remyelinate these activated neural circuits. This Localized Oligodendrocyte Optimization Therapy (LOOT) was highly effective in preclinical animal studies so this clinical trial aims to answer if this therapy will translate to humans.\n\nThe study is an adaptive design intended to compare the efficacy of the drug in the presence or absence of the engineered sound for improving hearing in noise ability. Trial participants will be tested for hearing thresholds and ability to isolate a sound signal from background noise. If they meet the inclusion criteria, they will be enrolled into one of the four arms of the study and undergo the proposed one-month treatment (drug and sound or respective placebos). After the treatment period, trial participants will be tested again for hearing thresholds and their ability to isolate s sound source of interest from background noise. The hypothesis to be tested in this clinical trial is that the one-month treatment will significantly improve the participant's ability to isolate a sound source of interest from background noise.\n\nThe design has four arms, drug+sound, placebo+sound, drug+white noise, and placebo+white noise. Based on our preclinical data, control arms are all expected to show identical results, thus our adaptive design includes interim analyses to allow for dropping of two of the three placebo arms should the preclinical results be replicated as anticipated.\n\nWe will also monitor each participant's general health during the duration of the clinical trial, which will be done by performing a number of blood tests, an EKG and a general physical before and after the one-month treatment period. We expect no significant changes since participants will take the drug for the one-month period at dosages already demonstrated safe in several Phase II studies of multiple sclerosis. Similarly, the engineered sound will be listened to for one hour per day during this month at sound intensities well below threshold that might cause noise-induced hearing damage.",[58,59,60,61,62,63,64,26,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"Central Auditory Processing Disorder","Hearing Impaired (Partially)","Hearing","Hearing Abnormality","Hearing Disability","Hearing Disorder","Hearing Disorders","Hearing Handicap","Hearing Impaired","Hearing Impairment","Hearing Loss","Central Auditory Disease","Noise Exposure","Noise Induced Hearing Loss","Noise-Induced Hearing Loss","Sound Perception","Myelin Degeneration","Myelinopathy","Myelin Integrity","Remyelination","Hidden Hearing Loss","Cocktail Party Skill","Cocktail Party Syndrome","CAPD","Age Problem",[84,78,85,86,87,88,89,90,91,92,81,93],"clemastine fumarate","Cocktail Party","Engineered Sound","Sound Therapy","central auditory processing disorder","Hearing in noise","oligodendrocyte","Localized Oligodendrocyte Optimization Therapy","LOOT","Age-Related Hearing Loss","2026-04-28",{"date":96,"type":32},"2026-04-30",{"date":98,"type":32},"2025-03-31",{"date":100,"type":20},"2028-07",{"name":102,"class":103},"University of Colorado, Denver","OTHER",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":40},"100545078","understanding-aided-speech-perception-in-noise-100545078","NCT06377215","Understanding Aided Speech Perception in Noise","Understanding Aided Speech Perception in Noise: Behavioral and Electrophysiological Measures","Inclusion Criteria:\n\nTarget candidates for this study will be 38 young normal-hearing (YNH), 38 older normal-hearing (ONH), and 55 older hearing-impaired (OHI) subjects. Eligible NH listeners will have ≤20 dB HL at octave frequencies from 0.25 to 4 kHz and ≤30 dB HL up to 8 kHz. Eligible HI listeners will have bilateral (symmetric), moderate sensorineural hearing loss characterized by pure-tone thresholds between 35 to 50 dB HL from 0.25 to 2 kHz and 50 to 70 dB HL between 3 and 8 kHz. Age is restricted from 60 to 80 years for the older listening groups and from 18 to 35 for younger listeners. A balance of male and female participants will be recruited to assess sex as a biological variable in the data analyses. This age range for older listeners was chosen to be maximally inclusive of potential presbycusic participants, to promote generality of the results, and to facilitate uniform sampling within this age range. The investigators want to avoid the scientific need to stratify by age, which would make the scope of the project unmanageable given the constraints of this five-year award. The investigators have no evidence that lower or higher ages would affect aided intervention. Thus, inclusion of a larger age range would weaken the rigor of the investigation and complicate interpretation of the findings. The target range of hearing loss was chosen for similar reasons, reflecting the largest segment of older adults with hearing loss while avoiding the need to stratify by hearing loss to evaluate the stated hypotheses.\n\nAdditional Inclusion Criteria for HI group:\n\n* Bilateral sensorineural hearing losses within the mild-to-moderately severe range as indicated by pure tone air- and bone-conduction audiometry and screening (Y-226 Hz, Type \"A\") tympanograms.\n* Candidates for hearing aids or experienced users.\n* Fluent speaker of English as speech testing will be in English.\n* MoCA (Montreal Cognitive Assessment; Nasreddine et al., 2005) score of \\> 22. This cut point has been used frequently in investigations of aging and will better ensure that cognitive related problems will not restrict the abilities of subjects to perform the study tasks.\n\nExclusion Criteria:\n\nExclusion criteria include conditions for which one could anticipate that hearing or cognitive status might change markedly during the course of study. To hedge against such changes, participants will be excluded if they have undergone clinical management for any of the following in the past 12 months:\n\n* Head trauma\n* Traumatic brain injury\n* Epilepsy\n* Seizures\n* Other neurological disorders\n* Otologic surgical procedures\n* Actively fluctuating hearing loss\n* Acute Meniere's disease\n* Labyrinthitis\n* Conductive hearing loss\n* Use of ototoxic medications",true,"80 Years",{"count":114,"type":20},121,[23],"The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention.",[26,118,119,120],"Spatial Perception","Aging","Hearing Aids",[122,123,124,125,126,127,128],"electrophysiology","binaural hearing","auditory scene analysis","auditory streaming","speech perception","localization","psychoacoustics","2025-12-19",{"date":131,"type":32},"2025-12-22",{"date":133,"type":32},"2025-11-16",{"date":135,"type":20},"2028-03-01",{"name":137,"class":103},"University of South Florida"]