[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"noise-exposure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:noise-exposure":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,71,106,168,201,224,254,279,302,336],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645018","measuring-the-evolution-of-speech-perception-in-noise-in-realistic-sound-environments-according-to-age-100645018",false,"NCT07675941","Measuring the Evolution of Speech Perception in Noise, in Realistic Sound Environments According to Age","SI 360","Inclusion Criteria:\n\n* Children with normal hearing (average hearing thresholds at 250 Hz, 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz less than 20 dB)\n* Be between 7 and 15 years old\n* Be a native French speaker, without bilingualism\n* Have typical development, as assessed by a school level corresponding to their age;\n* No objection from at least one of the two legal guardians\n* Legal guardian registered with social security\n* Able to understand instructions and information provided\n\nExclusion Criteria:\n\n* Inability of the child to respond to tests\n* Abnormal hearing thresholds\n* Speech disorder treated by speech therapist\n* Inability to understand instructions \u002F to respond to tests\n* Neurological conditions\n* Multiple disabilities\n* Ongoing treatment that may affect alertness\n* Unstable ADHD\n* History of tympanic surgery for chronic otitis media\n* Legal impossibility",true,"ALL","7 Years","15 Years",{"count":21,"type":22},150,"ESTIMATED","OBSERVATIONAL","In clinical settings, hearing perception is typically assessed using audiometric tests administered in a controlled environment. To date, these tests are administered in silence or in the presence of noise from fixed sources at an arbitrarily predetermined signal-to-noise ratio. These assessment situations are not representative of the functional difficulties encountered by people with hearing loss or Auditory Processing Disorder in their daily lives. In real life, \"soundscapes\" are diverse. Hearing assessment and rehabilitation should include the child's everyday environments as well as their lifestyle habits.\n\nThe Immersion 360 System (Virtual reality system) was developed specifically to virtually reproduce complex everyday sound experiences with realistic noise types and sound presentation conditions, enabling the assessment of auditory perception under test conditions similar to those encountered in daily life. Some of the sound environments offered by this innovative system have been standardized for adults. No standards exist for children, and we have limited knowledge regarding the development of speech perception skills in noise during childhood and adolescence. It seems essential to measure the age-related development of speech perception in realistic sound environments in order to establish reference data for children and adolescents.\n\nThis work will, through functional assessments of the auditory system and linguistic tests (speech perception in noise), provide a better understanding of the functional development of the central auditory system for speech perception in noise. The results collected from normo-hearing individuals in the age groups of interest will provide a clinical baseline for comparison with patients of the same age.",[26,27,28],"Noise Exposure","Normal Hearing","Child","NOT_YET_RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-30","ACTUAL",{"date":35,"type":22},"2026-07",{"date":37,"type":22},"2027-07",{"name":39,"class":40},"University Hospital, Toulouse","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":52,"conditions":53,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":41},"100577751","hospital-environmental-exposure-100577751","NCT06802367","Hospital Environmental Exposure","Environmental Exposures in a Clinical Setting: the Impact on Patients","Inclusion Criteria:\n\n* Hospital admission with a diagnosis that requires at least 2 nights.\n* Participant is willing and able to give informed consent for participation in the study. If a patient for example has dementia and\u002F or the inability to retain information or if they are unable to wear the device, they will not be consented.\n* Aged 18 years or above.\n* Able (in the ward staff, research team and investigator's opinion) and willing to comply with all study requirements.\n\nExclusion Criteria:\n\n* Any significant disease or disorder which, in the opinion of the investigator, may either put the participants or other patients at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n* Reported history of sleep disorders, including obstructive sleep apnoea syndrome (OSAS) or insomnia.","18 Years",{"count":51,"type":22},120,"There is an increasing body of evidence that human health is affected by environmental factors such as air quality, noise and light. This applies to both indoor and outdoor environments. While there have been several studies looking at homes, offices and work environments, hospital environments are still poorly characterised. Indoor hospital environments are complex, and patients with various health conditions can spend extended periods of time in wards. A number of studies have reported an association of air pollution exposure and a disturbance to sleep. A lack of sleep, or poor and disrupted sleep can impact health. Disturbed sleep therefore can impact a patient's recovery in hospital wards. In addition to the exposure to air pollutants, noise and light levels within the hospital environment can also have an impact on patient health. Inadequate, or a disrupted light and dark cycles can impact the circadian rhythm of the human body, responsible for the sleep cycle. In this study, the investigators aim to characterise these exposures and address the impact of these exposures on the patient sleep. Given the links between sleep and the environmental conditions.",[54,55,26,56,57],"Environment","Sleep","Air Quality","Light",[59,60,57,55],"Air quality","Noise","RECRUITING","2026-06-04",{"date":64,"type":33},"2026-06-08",{"date":66,"type":33},"2025-04-08",{"date":68,"type":22},"2026-12",{"name":70,"class":40},"University of Leicester",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":91,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":41},"100640066","fatigue-and-hearing-performance-of-healthy-volunteers-acutely-exposed-to-occupational-noise--fatigaudit-100640066","NCT07604077","Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FATIGAUDIT)","Fatigue and Hearing Performance in Healthy, Normal-hearing Volunteers Acutely Exposed to Occupational Noise Not Requiring Personal Protection. FATIGAUDIT","FATIGAUDIT","Inclusion Criteria:\n\n* Healthy subjects aged between 18 and 35\n* With normal pure-tone audiometry data (air and bone conductions) on both ears: hearing thresholds ≤20 dB HL for each frequency tested - 125, 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz\n* With normal Speech-in-noise test (the speech reception threshold (SRT) at which 50% recognition of the speech stimuli presented is achieved must be 3 dB higher than the standard test value established in subjects with normal hearing)\n* Without history of excessive noise exposure (1-MINUTE NOISE SCREEN ≤4)\n\nExclusion Criteria:\n\n* History of sudden deafness or tinnitus lasting more than 48 hours\n* Conditions likely to affect hearing (tumours of the ear or base of the skull, etc.)\n* History of unresolved chronic otitis\n* Work in a noisy environment requiring workplace soundproofing or the use of personal protective equipment\n* Migraine with or without aura or tension-type headaches (International Headache Society (IHS) classification)\n* Pregnant or breastfeeding women or women of childbearing age not using contraception\n* Participation in another interventional clinical trial\n* A person whose physical and\u002For psychological health is severely impaired\n* Individuals deprived of their legal capacity, or under guardianship or trusteeship\n* Persons deprived of liberty (by judicial or administrative decision)\n* Not affiliated to a French social security system or not a beneficiary of this system\n* Absence written informed consent to participate in the study","35 Years",{"count":81,"type":22},40,"INTERVENTIONAL",[84],"NA","Occupational noise exposure is regulated by law, and protective measures are applied if the noise level exceeds 90 dB(A). The inferior exposure levels can cause an auditory fatigue which is defined as temporary and reversible hearing loss. Its mechanisms, however, remain largely underexplored with recent animal data suggesting that the long-term exposure (over several weeks) to noise above 85 dB Sound Pressure Level (SPL) may provoke a permanent damage to hearing. Furthermore, there is also a lack of research on cognitive and attentional repercussions of this phenomenon. Yet, this information could be important to prevent work-related errors and accidents. Lastly, although silent breaks (noise-free resting periods) throughout a day of work are preconized to limit the noise exposure, their effect on auditory fatigue has never been demonstrated.\n\nBeing a part of a larger project involving fundamental researchers (animal experimentation) and occupational health specialists (investigations at the workplace), this study aims:\n\n* to evaluate how auditory fatigue caused by acute noise exposure in doses tolerated by law impacts auditory and cognitive performances in humans\n* to determine the effect of silent breaks proposed by occupational legislation on cognitive functioning\n* to issue new recommendations for the protection of workers exposed to noise",[87,88,26,89,90],"D001305","Auditory Fatigue","Environmental Noise","Auditory Performance",[92,93,94,95,96,97],"Audiometry","pure-tone audiometry","Speech audiometry","audiometric threshold","speech intelligibility threshold","acoustic reflex threshold","2026-05-15",{"date":100,"type":33},"2026-05-22",{"date":98,"type":22},{"date":103,"type":22},"2028-02-15",{"name":105,"class":40},"University Hospital, Montpellier",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":82,"phases":118,"briefSummary":121,"conditions":122,"keywords":148,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":41},"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":117,"type":22},344,[119,120],"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.",[123,124,125,126,127,128,129,130,131,132,133,134,135,26,136,137,138,139,140,141,142,143,144,145,146,147],"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 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",[149,143,150,151,152,153,154,155,156,157,146,158],"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":161,"type":33},"2026-04-30",{"date":163,"type":33},"2025-03-31",{"date":165,"type":22},"2028-07",{"name":167,"class":40},"University of Colorado, Denver",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":82,"phases":177,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":41},"100635568","a-multilevel-intervention-to-prevent-noise-exposure-in-farmworkers-100635568","NCT07554378","A Multilevel Intervention to Prevent Noise Exposure in Farmworkers","POP","Inclusion Criteria:\n\n* Age 18 years or older\n* Currently employed as a farmworker or supervisor at a participating farm\n* Able to provide informed consent\n* Able to understand and communicate in Spanish or English\n\nExclusion Criteria:\n\n* Not currently working at a participating farm at the time of recruitment\n* Unable or unwilling to wear a personal noise dosimeter during a work shift\n* Unable to complete study procedures (e.g., surveys or training)",{"count":176,"type":22},200,[84],"This study will test a program to reduce noise exposure and prevent hearing loss among farmworkers. Farmworkers are often exposed to high levels of noise from machinery, which can lead to hearing loss over time.\n\nFarms will be randomly assigned to either receive the program or serve as a comparison group. The program includes a short educational video, group discussion, and hands-on training on how to use hearing protection (such as earplugs). Supervisors will also receive brief training on how to support hearing protection use in the workplace.\n\nParticipants will wear a small device (dosimeter) during a work shift to measure noise exposure before the program and again about one month later. Participants will also complete surveys about their knowledge, attitudes, and behaviors related to hearing protection.\n\nA subset of participants will be invited to take part in interviews to understand barriers and facilitators to using hearing protection and implementing the program.\n\nThe results of this study will help inform future efforts to improve hearing health and reduce noise exposure in agricultural settings.",[26,180,181],"Hearing Loss, Noise-Induced","Occupational Exposure",[183,184,185,186,187,188,189,190,191,192],"farmworkers","agriculture","hearing protection","earplugs","occupational noise","hearing conservation","implementation science","Community Health Workers","Workplace intervention","Cluster randomized trial","2026-04-21",{"date":159,"type":33},{"date":196,"type":22},"2026-10",{"date":198,"type":22},"2032-07",{"name":200,"class":40},"San Diego State University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":205,"acronym":173,"eligibilityCriteria":206,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":82,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100613799","preventing-noise-exposure-in-farmworkers-100613799","NCT07271290","Preventing Noise Exposure in Farmworkers","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Currently employed as a farmworker in agricultural settings with routine exposure to occupational noise\n* Able to understand and provide informed consent in Spanish or English\n\nExclusion Criteria:\n\n* Not currently employed as a farmworker\n* Medical or ear conditions that preclude safe use of foam earplugs (e.g., acute ear infection, recent ear surgery)\n* Inability to complete study procedures as determined by study staff",{"count":208,"type":22},15,[84],"This study will evaluate a farmworker-level hearing loss prevention training designed to improve hearing protection use among farmworkers exposed to hazardous occupational noise. The intervention consists of a culturally and linguistically adapted, Spanish-language digital training module paired with hands-on earplug fitting and coaching.\n\nThe primary goals of the study are to (1) assess the feasibility and acceptability of delivering the adapted training in community-based settings, and (2) estimate preliminary effectiveness using an objective measure of hearing protection fit. The study uses a single-arm, pre-post pilot design.\n\nA small group of farmworkers will complete pre- and post-training assessments of earplug fit, as well as brief surveys assessing hearing protection knowledge, attitudes, and perceptions. Qualitative feedback will be collected to inform refinement of the training and guide future scale-up.\n\nResults will inform the development of a subsequent multilevel intervention that integrates supervisor and organizational components.",[26],[213,214,215],"noise exposure","hearing loss","farmworker","2026-02-11",{"date":218,"type":33},"2026-02-17",{"date":220,"type":22},"2026-10-01",{"date":222,"type":22},"2031-01-01",{"name":200,"class":40},{"id":225,"slug":226,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":231,"enrollmentInfo":232,"targetDuration":234,"studyType":23,"phases":4,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100607911","effect-of-operating-room-noise-on-bis-and-hemodynamics-under-general-anesthesia-100607911","NCT07194707","Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia","The Effect of Operating Room Environmental Noise on BIS and Hemodynamics in Patients Under General Anesthesia: A Prospective Observational Study","Inclusion Criteria:\n\n* Adults aged 18-70\n* ASA (American Society of Anesthesiologists) physical status score I-II\n* Scheduled for elective surgery\n* To be undergoing general anesthesia\n* Having signed the informed consent form to participate in the study\n\nExclusion Criteria:\n\n* Hearing impairment or ear pathology\n* History of neurological disease (epilepsy, stroke, dementia, etc.)\n* Use of psychiatric medications (anxiolytics, antidepressants, antipsychotics, etc.)\n* Indications for emergency surgery\n* Planned spinal or epidural anesthesia\n* Conditions unsuitable for BIS monitoring\n* Cognitive impairment preventing informed consent","70 Years",{"count":233,"type":22},70,"1 Day","This prospective observational study aims to evaluate the impact of operating room noise on bispectral index (BIS) and hemodynamic parameters in patients undergoing general anesthesia. Environmental noise in operating rooms, often overlooked, may influence anesthesia depth, patient safety, and physiological stability. A total of 70 adult patients (ASA I-II, 18-65 years, elective surgery under general anesthesia) will be enrolled at Başakşehir Çam and Sakura City Hospital. Patients will be categorized into two groups based on intraoperative average noise levels: noisy group (\\>65 dB) and quiet group (\\\u003C55 dB). Noise levels will be measured every 10 minutes using a CEM DT-8850 sound level meter, BIS will be recorded every 10 minutes, and hemodynamic variables (systolic, diastolic, mean arterial pressure, and heart rate) will be recorded every 5 minutes.\n\nPrimary outcome is the correlation between mean intraoperative noise levels (LAeq) and BIS values during the maintenance phase of anesthesia. Secondary outcomes include the relationship between noise characteristics (e.g., device-related, human-related, alarms, media) and hemodynamic stability, as well as surgical branch-related noise classifications (high, moderate, low). The study is non-interventional, with no additional risk to participants beyond standard clinical monitoring. Findings are expected to provide evidence on the role of environmental noise in anesthesia quality, inform operating room organization, and contribute to patient safety improvements.",[237,238,26],"General Anesthesia","Hemodynamics",[240,241,242,238,243,26],"Anesthesia, General","Operating Rooms","Monitoring, Intraoperative","Bispectral Index (BIS)","2026-01-03",{"date":246,"type":33},"2026-01-06",{"date":248,"type":22},"2026-02-01",{"date":250,"type":22},"2026-06-01",{"name":252,"class":253},"Başakşehir Çam & Sakura City Hospital","OTHER_GOV",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":115,"enrollmentInfo":261,"targetDuration":4,"studyType":82,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":41},"100604384","impact-of-earplugs-on-mechanisms-of-noise-related-cardiovascular-disease-100604384","NCT07148817","Impact of Earplugs on Mechanisms of Noise-Related Cardiovascular Disease","Impact of Personal Mitigation on Mechanisms Linking Transportation Noise Exposure to Cardiometabolic Disease","Inclusion Criteria:\n\n* Describe feeling annoyed by transportation noise exposure or have high residential noise exposure (\\>45 dBA average over 24 hours) using the United States Department of Transportation Map\n* Known stable atherosclerosis or at least one typical risk factor (i.e., hypertension, diabetes, active smoking, or hyperlipidemia)\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* History of stroke, brain surgery, or seizure\n* Use of certain CVD medications (e.g., beta-blockers, high-intensity statins \\[e.g., rosuvastatin 20\u002F40 mg and atorvastatin 40\u002F80 mg\\], PCSK-9 inhibitors)\n* Psychiatric or cardiovascular medication change within 3 months (i.e., stable regimen is allowed)\n* Unstable blood pressure or cardiac arrhythmia\n* Current use of personal noise mitigation techniques or involvement in stress management program\n* Moderate\u002Fsevere alcohol\u002Fsubstance use disorder\n* Current mania\u002Fpsychosis\n* Weight \\>300 lbs.\n* Claustrophobia\n* Pregnancy\n* Metal implants\n* Uncontrolled hyperglycemia (HgbA1c\\>7.5%)\n* Subjects who have had significant radiation exposure as part of research (\\>2 nuclear tests, computed tomography images, or fluoroscopic procedures) during the preceding 12-months",{"count":262,"type":22},26,[84],"Noise from cars, planes, and trains affects all people and has been associated with heart disease. Almost 30% of Americans are exposed to harmful levels of noise and noise accounts for the loss of more than one million healthy life years per year in Europe. Noise causes stress and may be most dangerous when it happens at night. The mechanisms linking noise to heart disease involve changes in the brain and the \"fight or flight\" response. These changes lead to inflammation and blood vessel disease. However, there are few laws that restrict noise and it is not addressed in medical care. Further, as cities and industries grow, noise continues to increase. Moreover, noise often occurs in areas that are also exposed to other stressors like high air pollution and low income. Yet, there is little research on noise, and it is not known if lowering noise exposure helps heart health. The investigators will use imaging to test if earplugs that block noise improve stress symptoms and changes in the the brain, blood vessels, and stress pathways that lead to disease. The investigators expect that people who use earplugs will have lower measures of stress and heart disease at follow-up. The study will include 26 people with heart disease risk with high noise exposure or who are annoyed by noise. At the first visit, subjects will have imaging of the brain and blood vessels and will have assessments of stress, inflammation, and the \"fight or flight\" response. They will be assigned to use earplugs or not after the first visit. After 6 months, imaging and other testing will be repeated. It will help to understand how noise impacts the body and whether the effects can be changed. It may also identify important treatments to prevent heart disease in people exposed to noise. By testing if the adverse effects of noise can be lowered with earplugs, this project supports the AHA's mission to be a force for a world of longer and healthier lives.",[266,26],"Cardiometabolic Diseases",[268,266,269],"Transportation Noise","Earplugs","2025-10-31",{"date":272,"type":33},"2025-11-03",{"date":274,"type":33},"2025-10-15",{"date":276,"type":22},"2028-06-30",{"name":278,"class":40},"Massachusetts General Hospital",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":285,"targetDuration":287,"studyType":23,"phases":4,"briefSummary":288,"conditions":289,"keywords":290,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":4},"100572936","research-on-the-sources-of-noise-in-post-anesthesia-care-unit-and-the-impact-of-noise-on-medical-staff-100572936","NCT06739746","Research on the Sources of Noise in Post Anesthesia Care Unit and the Impact of Noise on Medical Staff","Inclusion Criteria:\n\n* Currently working as nurses, doctors, or technicians in the Post Anesthesia Care Unit;\n* Have at least continuous 6 months of work experience in the Post Anesthesia Care Unit;\n* Able to read and answer questionnaires in Chinese fluently.\n\nExclusion Criteria:\n\n* Have hearing impairments or other conditions affecting auditory perception;\n* Have participated in similar studies and completed related surveys within the past 6 months.",{"count":286,"type":22},400,"1 Week","The study aims to clarify the sources and influencing factors of noise in the post anesthesia care unit, as well as the perception of noise by medical staff through survey table, in order to improve the noise environment, optimize noise management, protect medical staff, and enhance medical quality.",[26],[60,291,292],"Post anesthesia care unit","Medical staff","2025-05-29",{"date":295,"type":33},"2025-05-31",{"date":297,"type":22},"2025-06-01",{"date":299,"type":22},"2025-12-31",{"name":301,"class":40},"First Affiliated Hospital of Chongqing Medical University",{"id":303,"slug":304,"hasResults":11,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":82,"phases":311,"briefSummary":312,"conditions":313,"keywords":319,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":41},"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","55 Years",{"count":310,"type":22},116,[84],"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).",[26,314,315,316,317,181,318,143],"Noise-induced Hearing Loss","Noise; Adverse Effect","Mild Therapeutic Hypothermia","Cooling","Occupational Health",[320,214,321,213,322,323,324,325],"hearing preservation","noise-induced hearing loss","mild therapeutic hypothermia","cooling","post-exposure","prevention","2025-03-28",{"date":328,"type":33},"2025-04-02",{"date":330,"type":33},"2024-12-19",{"date":332,"type":22},"2026-12-31",{"name":334,"class":335},"Restorear Devices LLC","INDUSTRY",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":115,"enrollmentInfo":343,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":41},"100538707","noise-oxidative-stress-and-cardiovascular-system-100538707","NCT06294340","Noise, Oxidative Stress and Cardiovascular System","NOXYCARD","Inclusion Criteria:\n\n* age 18-65\n* both genders\n* good self-reported health\n\nExclusion Criteria:\n\n* diabetes mellitus\n* arterial hypertension or other cardiovascular diseases\n* kidney diseases\n* pregnancy\n* malignant diseases\n* mental diseases",{"count":21,"type":22},"Environmental noise represents a health problem for at least one in five citizens of the European Union. Noise exposure leads to the development of arterial hypertension, myocardial infarction, stroke, and obesity. Given the limited information on noise exposure and noise effects on humans in the Republic of Serbia, the overall objective of NOXYCARD is to collect environmental noise levels data; to identify long-term and short-term noise effects on the cardiovascular system; and to evaluate the levels of blood stress hormones, oxidative stress, and inflammation in individuals with normal body weight and individuals with obesity.",[315,26],"2024-02-27",{"date":348,"type":33},"2024-03-05",{"date":350,"type":22},"2025-01",{"date":352,"type":22},"2028-12",{"name":354,"class":40},"University of Belgrade"]