[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-handicap\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-handicap":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":55,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100616316","phase-1-a-treatment-for-a-form-of-age-related-central-auditory-processing-disorder-consisting-of-clemastine-fumarate-plus-engineered-sound-100616316",false,"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.","ALL","45 Years","65 Years",{"count":21,"type":22},344,"ESTIMATED","INTERVENTIONAL",[25,26],"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.",[29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54],"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","Hidden Hearing Loss","Cocktail Party Skill","Cocktail Party Syndrome","CAPD","Age Problem",[56,50,57,58,59,60,61,62,63,64,53,65],"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","RECRUITING","2026-04-28",{"date":69,"type":70},"2026-04-30","ACTUAL",{"date":72,"type":70},"2025-03-31",{"date":74,"type":22},"2028-07",{"name":76,"class":77},"University of Colorado, Denver","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":17,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100578513","mediators-and-moderators-of-auditory-training-100578513","NCT06812273","Mediators and Moderators of Auditory Training","Inclusion Criteria:\n\n* 18-30 and 60-85 years of age.\n* No self-reported auditory difficulties and normal or near-normal hearing sensitivity as measured by SRTs.\n* Older adults aged 50-85 should have no more than typical hearing loss for their age and no evidence of dementia.\n* Fluent in English and\u002For Spanish\n\nExclusion Criteria:\n\n* Abnormal vision or hearing prohibitive of training\n* History of seizures, focal brain lesion, or head injury with loss of consciousness\n* Physical handicap (motor or perceptual) that would impede training procedures\n* Medical illness requiring treatment during the study timeline\n* Social, educational or economic hardship prohibitive to training schedule\n* Concurrent enrollment in other cognitive training studies\n* History of major psychiatric illness, including psychosis, bipolar disorder, depression, alcohol or substance abuse, recent bereavement\n* Plans to travel out of the area for more than 1 week during the intervention period\n* Residence too far from the testing site, which would prevent attending the testing sessions (\\> 60 miles)\n* Not being proficient enough in English or Spanish that would prevent following and understanding all instructions and completing all testing sessions\n\nAdditional exclusion criteria for older adults:\n\n* Diagnosis of dementia or other neurological disease, including mild cognitive impairment (MCI)\n* Telephone-Montreal Cognitive Assessment (t-MoCA) score of 16 or less or Montreal Cognitive AssessmentMoCA) score of 20 or less",true,"18 Years","85 Years",{"count":89,"type":22},1260,[91],"NA","The goal of this clinical trial is to learn how Auditory Training (AT) may help people better understand speech in noisy environments. As people get older, it becomes harder for them to hear speech clearly when there is background noise. This can be frustrating, and it can affect their independence and quality of life. AT is often used to support people with and without hearing loss, especially when a person is not a good candidate for a hearing aid or when amplification from a hearing aid does not improve performance.\n\nThe investigators want to gather reliable data to understand how AT works and what affects its success.\n\nThe main questions the trial aims to answer are:\n\n* How do different types of sounds influence the effectiveness of auditory training?\n* Which auditory training approaches are most successful in improving speech understanding?\n* How do personal traits impact the results of auditory training?\n\nThe investigators will study a large and diverse group of 1,260 participants, including both young and older adults, to evaluate various auditory training approaches.\n\nYou will:\n\n* Take part in auditory training sessions that include different types of auditory tasks.\n* Complete tests that measure how well they understand speech in both quiet and noisy settings.\n* Complete surveys on personal data like demographics, hearing challenges and other factors to help researchers understand what might influence training results.\n\nThe investigators will measure and compare the results of these approaches to find out which ones are most effective. This could help people who are at risk of cognitive decline, like those at risk for Alzheimer's disease.",[37],[95,96,97],"audition","auditory training","cognition","2026-04-15",{"date":100,"type":70},"2026-04-20",{"date":102,"type":70},"2025-01-06",{"date":104,"type":22},"2027-05-31",{"name":106,"class":77},"Northeastern University",3]