[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hearing-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hearing-disorder":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,115,140,170],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100318690","biospecimen-procurement-for-head-and-neck-disorders-100318690",false,"NCT03429036","Biospecimen Procurement for Head and Neck Disorders","Biospecimen Procurement for the Study of Head and Neck Disorders","* INCLUSION CRITERIA:\n* Age 3 and older.\n* Able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.\n* Diagnosis of a condition of the head and neck for which removal of biological specimens was indicated for clinical care or for research purposes under a separate Review Board (IRB) approved protocol.\n* Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Part 1:\n\n  --Are unwilling to share waste specimens for research purposes\n* Part 2: Additional exclusion criteria for the Part 2 prospective sample collection part of this protocol these criteria may be assessed prior to collection of the samples but will not affect overall eligibility for the trial (i.e., Part 1):\n\n  * have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction\n  * have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the participants risk in participating. This will be determined at the discretion of the principal investigator\n  * Individuals under the age of 18 are excluded from oral mucosal biopsies and skin biopsies","ALL","3 Years","120 Years",{"count":20,"type":21},1000,"ESTIMATED","OBSERVATIONAL","Background:\n\nResearchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.\n\nObjective:\n\nTo create a repository of tissue samples and data to better study conditions of the head and neck.\n\nEligibility:\n\nPeople who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.\n\nDesign:\n\nParticipants will be screened with a questionnaire, medical history, and physical exam.\n\nPart 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.\n\nIf participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.\n\nPart 2: Participants will have additional samples collected. These could be:\n\n* Blood: Blood is drawn through a needle in the arm.\n* Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.\n* Saliva: They rinse their mouth with water and spit into a tube or cup.\n* Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.\n* Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.\n\nParticipants samples will be used for future research, including genetic testing.",[25,26,27,28,29],"Hearing Disorder","Oral Mucosal Disease","Pharyngeal Neoplasm","Head and Neck Neoplasms","Laryngeal Disease",[31,32,33,34,35,36],"Genomic DNA","DNA Banking","Tissue Sample","Saliva","Blood Collection","Natural History","RECRUITING","2026-06-10",{"date":40,"type":41},"2026-06-11","ACTUAL",{"date":43,"type":41},"2018-05-23",{"date":45,"type":21},"2029-12-02",{"name":47,"class":48},"National Cancer Institute (NCI)","NIH",9,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":93,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":114},"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":61,"type":21},344,"INTERVENTIONAL",[64,65],"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.",[68,69,70,71,72,25,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92],"Central Auditory Processing Disorder","Hearing Impaired (Partially)","Hearing","Hearing Abnormality","Hearing Disability","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",[94,88,95,96,97,98,99,100,101,102,91,103],"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":106,"type":41},"2026-04-30",{"date":108,"type":41},"2025-03-31",{"date":110,"type":21},"2028-07",{"name":112,"class":113},"University of Colorado, Denver","OTHER",1,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":62,"phases":124,"briefSummary":126,"conditions":127,"keywords":128,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":114},"100623923","evaluation-of-cochlear-promontory-stimulation-during-awake-ear-surgery-tones-study-100623923","NCT07402941","Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)","Inclusion Criteria:\n\n1. Individual is ≥ 18 years old at the time of consent.\n2. Individual is scheduled for awake ear surgery that will expose the middle ear (subannular tympanostomy tube placement, tympanoplasty, stapes surgery).\n3. Individual is willing to complete intraoperative assessments of promontory stimulation.\n\nExclusion Criteria:\n\n1. Individual has had severe-to-profound hearing loss for more than 30 years.\n2. Individual has congenital hearing loss (for the purpose of this study, onset prior to 2 years of age)\n3. Ear canal will not accommodate a speculum with minimum outer diameter (OD) of 4.0 mm or other anatomic challenges present as determined by the study investigator\n4. Hearing loss or auditory processing disorder of neural or central origin\n5. Active middle ear infection\n6. History of cholesteatoma treated within the past 2 years\n7. Ossification of the cochlear or other previously identified cochlear anomaly\n8. Prior major head trauma (stroke, hemorrhage, traumatic brain injury) within past 2 years\n9. Contralateral presence of cochlear implant\n10. Individual is pregnant.\n11. Individual is unable or unwilling to complete training for qualitative evaluation of promontory electrical stimulation.\n12. A disability that could interfere with intraoperative evaluations as determined by study investigator.\n13. Profound tinnitus\n14. History of vertigo that would interfere with the planned investigation as determined by the principal investigator","18 Years",{"count":123,"type":21},18,[125],"NA","The goal of this clinical trial is to learn if short electrical signals can be heard in adult subjects who are otherwise having surgery on their ear.\n\nThe main question it aims to answer is:\n\nCan an individual accurately hear different frequencies resulting from the short electrical signals?",[25],[70,129],"Cochlea","2026-02-04",{"date":132,"type":41},"2026-02-11",{"date":134,"type":41},"2025-06-02",{"date":136,"type":21},"2026-07",{"name":138,"class":139},"Auricle Health Inc.","INDUSTRY",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":16,"minAge":121,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":62,"phases":151,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":166,"leadSponsor":168,"locationsCount":4},"100599822","impact-of-anesthesia-alarm-volume-on-mental-workload-in-surgical-trainees-100599822","NCT07089485","Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees","Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees: A Randomized Pilot Simulation Study","ASLEC02","Inclusion Criteria:\n\n* Surgical residents or experienced surgeons;\n* Surgeons with normal hearing;\n* Surgeons capable of performing surgical sutures (regardless of skill level);\n* Surgeons able and willing to follow all study procedures according to the protocol;\n* Surgeons who have understood, signed, and dated the informed consent form provided on the day of enrollment.\n\nExclusion Criteria:\n\n* Surgeons undergoing beta-blocker treatment;\n* Surgeons with known cardiac pathology;\n* Surgeons who do not consent to participate in the study;\n* Surgeons with known hearing problems;\n* Surgeons who fail the hearing test;\n* Surgeons who worked on-call or night shifts during the night before the evaluation day.\n* Surgical trainees at the Lorraine Cancer Institute.\n* Adults under legal protection (guardianship, curatorship, or legal supervision);Persons deprived of liberty;Pregnant or breastfeeding women.",true,{"count":150,"type":21},26,[125],"Noise in hospital environments, particularly in operating rooms, poses challenges to both patient comfort and healthcare professionals' performance. Among the sources of noise, anesthesia monitoring alarms are essential for patient safety, yet no clear guidelines exist regarding their optimal sound level. Excessive alarm volume may increase distraction and cognitive load, especially for surgical trainees, potentially impairing their focus and performance during procedures. This randomized pilot interventional study aims to evaluate the impact of anesthesia alarm sound intensity on the mental workload of surgical trainees performing simulated surgeries. Participants will be randomly assigned to conditions with either an optimized alarm volume or a higher standard volume during simulated tasks. Cognitive load will be assessed using objective physiological measures such as heart rate variability and pupillometry, as well as subjective evaluations with tools like the NASA-TLX and SURG-TLX scales. The primary goal is to determine whether an optimized alarm sound level can reduce cognitive strain without compromising vigilance required for patient safety. Findings from this study are expected to provide evidence-based recommendations for auditory ergonomics in operating rooms, ultimately improving working conditions for surgical teams and enhancing both training and patient safety.",[154,155,25,156],"Surgical Procedures","Noise","Mental Workload",[158,159,160],"Noise\u002Fadverse effects","Cognition Disorders","Surgical procedures","NOT_YET_RECRUITING","2025-09-22",{"date":164,"type":41},"2025-09-25",{"date":164,"type":21},{"date":167,"type":21},"2026-09-26",{"name":169,"class":113},"Institut de Cancérologie de Lorraine",{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":148,"sex":16,"minAge":178,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":62,"phases":181,"briefSummary":182,"conditions":183,"keywords":193,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":4},"100583907","holistic-integration-for-healthy-longevity-and-aging-in-place-100583907","NCT06882434","Holistic Integration for Healthy Longevity and Aging in Place","Holistic Integration for Healthy Longevity and Aging in Place - Establishing Full-spectrum Community-based Care System for Older People to Maintain Wellbeing Pursuing Abilities","HIHOPE","Inclusion Criteria:\n\n* Age ≥55 years (includes older adults and pre-elderly individuals).\n* No severe functional disability (must be able to walk independently, use assistive devices, or operate a wheelchair independently).\n* No severe cognitive impairment (must be able to respond appropriately to verbal questions).\n\nExclusion Criteria:\n\n* Irregular community participation (less than once per week in the target community).\n* Mild dementia or greater (assessed during screening). If identified, family members will be notified, and they retain the right to withdraw the participant unconditionally.","55 Years",{"count":180,"type":21},600,[125],"Background:\n\nTaiwan is experiencing rapid population aging, with a growing prevalence of chronic diseases and functional impairments among older adults. Existing Integrated Care for Older People (ICOPE) programs focus primarily on screening but lack sufficient follow-up and intervention. In response, the HI-HOPE Project was developed to establish a community-based, multidisciplinary intervention model to enhance intrinsic capacity and promote healthy aging in rural elderly populations.\n\nSurvey and Screening:\n\nThe study will be conducted in 30 community centers across Yunlin County, targeting older adults aged ≥55 years. Participants will undergo biannual screenings over two years, assessing cognitive function, depression, mobility, vitality (nutrition), hearing, vision, osteoporosis, polypharmacy, urological health, and social participation \\& welfare.\n\nIntervention:\n\nParticipants will be randomly assigned to either:\n\nHI-HOPE Integrated Care Group:\n\nOn-Site Community Interventions: Exercise training, mindfulness, social activities, oral and swallowing rehabilitation, hearing and vision training.\n\nTelehealth \\& Remote Education: Digital health monitoring, remote consultations, and health education.\n\nReferral Services: Access to specialized medical care, transportation assistance, and follow-up support.\n\nControl Group: Standard community care services without additional structured interventions.\n\nOutcome Measures:\n\nPrimary outcomes include changes in intrinsic capacity of functional health metrics, including abnormalities of I-COPE components (mobility, cognitive status, depression, hearing, vision, vitality) . Secondary outcomes assess quality of life, activities of daily living, hospitalization, emergency visits, falls, and mortality rates over two years.\n\nSignificance:\n\nThis project integrates digital health technologies, interdisciplinary care, and community-based interventions to improve elderly health outcomes. The findings will guide the future scalability of integrated aging care models in Taiwan and beyond.",[184,185,186,187,188,25,189,190,191,192],"Cognitive Decline","Sarcopenia","Depression Disorders","Nutrition Disorder","Swallowing Difficulties","Visual Disorder","Osteoporosis","Urologic Disorders","Polypharmacy",[176,194,195,196,197,198,199,200,201,202,203,204,205],"I-COPE","dementia","depression","dysphagia","nutrition","sarcopenia","frailty","hearing disorder","visual disorder","osteoporosis","urologic disorder","polypharmacy","2025-03-20",{"date":208,"type":41},"2025-03-25",{"date":210,"type":21},"2025-03-15",{"date":212,"type":21},"2028-12-31",{"name":214,"class":113},"National Taiwan University Hospital"]