[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hidden-hearing-loss\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hidden-hearing-loss":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,104,132],{"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":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642147","hidden-hearing-loss-in-older-adults-100642147",false,"NCT07646119","Hidden Hearing Loss in Older Adults","Hidden Hearing Loss in Older Adults: Mechanisms of Speech-in-noise Perception Deficits and Associated Central Compensation","Inclusion Criteria:\n\n1. Aged 60 years or older;\n2. Bilateral pure-tone average hearing thresholds across 0.5, 1, 2, and 4 kHz ≤ 25 dB HL;\n3. Self-reported hearing difficulties identified during previous hearing screening;\n4. Fluent in Mandarin Chinese;\n5. No history of otologic disease, ear trauma, ototoxic medication history, or long-term noise exposure;\n6. No known neurological or psychiatric disorders, or other major medical conditions that may affect nervous system function.\n\nExclusion Criteria:\n\n1. Unable to comply with or complete the study assessments;\n2. Mini-Mental State Examination (MMSE) score \\\u003C 24 during previous health screening;\n3. Refuse to participate in the study","ALL","60 Years",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to investigate whether speech-in-noise perception deficits in older adults aged 60 years or older with objectively normal hearing thresholds are due to impaired ability of processing temporal cues in speech signals. The study further aims to examine whether cognitive and cortical mechanisms provide compensatory support for speech perception in challenging listening environments.",[24],"Hidden Hearing Loss",[26,27],"Cochlear Synaptopathy","Age-related Hearing Loss","RECRUITING","2026-06-09",{"date":31,"type":32},"2026-06-12","ACTUAL",{"date":34,"type":20},"2026-06-15",{"date":36,"type":20},"2027-05-30",{"name":38,"class":39},"Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University","OTHER",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":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":84,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"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,"INTERVENTIONAL",[55,56],"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.",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,24,80,81,82,83],"Central Auditory Processing Disorder","Hearing Impaired (Partially)","Hearing","Hearing Abnormality","Hearing Disability","Hearing Disorder","Hearing Disorders","Hearing Impairment, Sensorineural","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","Cocktail Party Skill","Cocktail Party Syndrome","CAPD","Age Problem",[85,24,86,87,88,89,90,91,92,93,82,94],"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":97,"type":32},"2026-04-30",{"date":99,"type":32},"2025-03-31",{"date":101,"type":20},"2028-07",{"name":103,"class":39},"University of Colorado, Denver",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":16,"minAge":112,"maxAge":17,"enrollmentInfo":113,"targetDuration":115,"studyType":21,"phases":4,"briefSummary":116,"conditions":117,"keywords":118,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":40},"100610642","relationship-between-ls-chirp-abr-and-speech-in-noise-skills-in-hidden-hearing-loss-100610642","NCT07230236","Relationship Between LS Chirp ABR and Speech-in-Noise Skills in Hidden Hearing Loss","Investigation of the Relationship Between LS Chirp ABR and Comprehension In Noise Skills In Individuals With Suspected Hidden Hearing Loss","Inclusion Criteria (Control group):\n\n* Being between 20 and 60 years of age,\n* Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),\n* Having no tinnitus or auditory complaints,\n* Scoring 21 or above on the MoCA test,\n* Having no emotional or neurological problems that could interfere with the tests.\n\nExclusion Criteria (Control group):\n\n* Presence of peripheral and\u002For central hearing loss,\n* Presence of somatosensory tinnitus,\n* Presence of emotional and\u002For neurological problems that could interfere with the tests.\n\nInclusion Criteria (First study group):\n\n* Being between 20 and 60 years of age,\n* Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),\n* Having a chronic tinnitus complaint (≥3 months),\n* Scoring 21 or above on the MoCA test,\n* Having no emotional or neurological problems that could interfere with the tests.\n\nExclusion Criteria (First study group):\n\n* Presence of peripheral and\u002For central hearing loss,\n* Presence of somatosensory tinnitus,\n* Presence of emotional and\u002For neurological problems that could interfere with the tests.\n\nInclusion Criteria (Second study group):\n\n* Being between 20 and 60 years of age,\n* Having bilateral pure-tone audiometry averages (500-1000-2000-4000 Hz) within the normal range (≤25 dB HL),\n* Having no chronic tinnitus complaint,\n* Having an average score below 4.3 on the \"Speech Perception\" subscale of the Speech, Spatial and Qualities of Hearing Scale (SSQ),\n* Scoring 21 or above on the MoCA test,\n* Having no emotional or neurological problems that could interfere with the tests.\n\nExclusion Criteria (Second study group):\n\n* Presence of peripheral and\u002For central hearing loss,\n* Presence of somatosensory tinnitus,\n* Presence of emotional and\u002For neurological problems that could interfere with the tests.",true,"20 Years",{"count":114,"type":20},63,"10 Months","It is known that the underlying problem in Hidden Hearing Loss (HHL) is cochlear synaptopathy (CS) and that low-spontaneous-rate auditory nerve fibers play an important role in this pathology. Therefore, it is suggested that low-spontaneous-rate auditory nerve fibers are damaged in HHL. Consequently, LS CE-Chirp-evoked ABR and HINT, which assesses CS by presenting stimuli of varying intensities and characteristics to provide information about auditory nerve fibers, will be used to evaluate participants both objectively and subjectively.\n\nAim of the study:\n\nThe main aim of this study is to investigate the relationship between the amplitude and latency values obtained with LS CE-Chirp-stimulated ABR and the critical Signal-to-Noise Ratio (SNR) obtained from the Hearing in Noise Test (HINT) in individuals suspected of having HHL.\n\nHypotheses\n\nH0: In individuals suspected of having HHL, there is no relationship between the amplitude values of waves I, III, and V obtained with LS CE-Chirp ABR at 80, 90, and 100 dBnHL and the I\u002FV amplitude ratio and the critical SNR obtained from HINT.\n\nH1: In individuals suspected of having HHL, there is a relationship between the amplitude values of waves I, III, and V obtained with LS CE-Chirp ABR at 80, 90, and 100 dBnHL and the I\u002FV amplitude ratio, and the critical SNR obtained from HINT.\n\nExpected Results:\n\nThe study will reveal how LS CE-Chirp stimulation affects ABR results in individuals suspected of having HHL, and the relationship between these results and HINT results will be examined. In this way, HHL will be evaluated both objectively (LS CE-Chirp ABR) and subjectively (HINT). Based on the findings, scientific outputs such as publications or projects are targeted.\n\nImportance:\n\nHHL has recently attracted increasing attention as a condition that significantly affects daily life. In today's world, where noise and noisy environments are prevalent, disadvantages arise in many aspects, particularly in communication. Therefore, the findings obtained in this study may contribute to a better understanding of HHL.",[24,26],[119,120,121,122],"hidden hearing loss","cochlear synaptopathy","Level-Specific (LS) Chirp ABR","Hearing In Noise Test (HINT)","2025-11-14",{"date":125,"type":32},"2025-11-17",{"date":127,"type":32},"2025-08-20",{"date":129,"type":20},"2026-06-01",{"name":131,"class":39},"Istanbul University - Cerrahpasa",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":111,"sex":16,"minAge":138,"maxAge":139,"enrollmentInfo":140,"targetDuration":4,"studyType":53,"phases":142,"briefSummary":144,"conditions":145,"keywords":152,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":40},"100572158","non-invasive-system-to-deliver-therapeutic-hypothermia-for-protection-against-noise-induced-hearing-loss-100572158","NCT06729632","Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss","Inclusion Criteria:\n\n* Adults aged 18-55 years old at the time of signing the consent form\n* Fluency in English\n\nExclusion Criteria:\n\n* Abnormal tympanometric findings\n* Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)\n* Significant history of noise exposure (Non-firefighters only)\n* Temporomandibular joint disorder\n* Otologic pathologies (including, but not limited to): acoustic neuroma\u002Fvestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity\n* Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions\n* Active hearing aid users\n* Adults unable to consent","18 Years","55 Years",{"count":141,"type":20},116,[143],"NA","The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are:\n\n1. To test the safety and best duration for use for a new hypothermia device.\n2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters.\n\nParticipants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).",[72,146,147,148,149,150,151,24],"Noise-induced Hearing Loss","Noise; Adverse Effect","Mild Therapeutic Hypothermia","Cooling","Occupational Exposure","Occupational Health",[153,154,155,156,157,158,159,160],"hearing preservation","hearing loss","noise-induced hearing loss","noise exposure","mild therapeutic hypothermia","cooling","post-exposure","prevention","2025-03-28",{"date":163,"type":32},"2025-04-02",{"date":165,"type":32},"2024-12-19",{"date":167,"type":20},"2026-12-31",{"name":169,"class":170},"Restorear Devices LLC","INDUSTRY"]