[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640066":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":47,"centralContacts":51,"locations":59,"responsibleParty":71,"collaborators":73,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":34,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":101,"overallStatus":108,"whyStopped":34,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 : 2H30 of non-stop noise exposure","EXPERIMENTAL","Group 1 (n=10) will be exposed to 85 dB(A) for 2h30 without any interruption of noise exposure",[13],"Other: 2h30 of noise exposure at 85 dB(A)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2 : 2 noise exposures of 66 min","Group 2 (n=10) will be exposed to 85.5 dB(A) for 66 minutes, followed by an 18-minute rest period, then exposed to noise again for 66 minutes, for a total noise exposure time equivalent to 85 dB(A) for 2.5 hours.",[18],"Other: 2 noise exposures of 66 minutes",{"label":20,"type":10,"description":21,"interventionNames":22},"Group 3 : 10 noise exposure cycles","Group 3 (n=10) will be exposed to 10 cycles of (13 minutes of noise at 85.6 dB(A) \u002F 2 minutes of rest), for a total duration of noise exposure equivalent to 85 dB(A) for 2h30.",[23],"Other: 10 noise exposure cycles",{"label":25,"type":6,"description":26,"interventionNames":27},"Group 4 : no noise exposure","Group 4 (n=10) will not be exposed to noise and will serve as a control.",[28],"Other: No noise exposure",[30,35,39,43],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"2h30 of noise exposure at 85 dB(A)","2h30 of uninterrupted noise exposure at 85 dB(A)",[9],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"2 noise exposures of 66 minutes","Exposure to 85.5 dB(A) noise for 66 minutes, followed by an 18-minute rest period, then exposure to noise again for 66 minutes",[15],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"10 noise exposure cycles","Exposure to 10 cycles of (13 minutes of noise at 85.6 dB(A) \u002F 2 minutes of rest)",[20],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":34},"No noise exposure","No exposure to noise: subjects spend 2H30 in a soundproof cabin.",[25],[48],{"name":49,"affiliation":5,"role":50},"Renan TARGHETTA","STUDY_DIRECTOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":34,"email":56},"Michel MONDAIN, Pr","CONTACT","+33 467336893","m-mondain@chu-montpellier.fr",{"name":58,"role":54,"phone":34,"phoneExt":34,"email":34},"Akil KADERBAY, Dr",[60],{"facility":61,"status":34,"city":62,"state":34,"zip":34,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":34},"CHU Gui de Chauliac, ENT & Head and Neck Surgery Department","Montpellier","France","FR",{"type":66,"coordinates":67},"Point",[68,69],3.87635,43.61093,{"lat":69,"lon":68},{"type":72,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[74],{"name":75,"class":6},"National Research Agency, France","100640066","fatigue-and-hearing-performance-of-healthy-volunteers-acutely-exposed-to-occupational-noise--fatigaudit-100640066",false,"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",true,"ALL","18 Years","35 Years",{"count":89,"type":90},40,"ESTIMATED","INTERVENTIONAL",[93],"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",[96,97,98,99,100],"D001305","Auditory Fatigue","Noise Exposure","Environmental Noise","Auditory Performance",[102,103,104,105,106,107],"Audiometry","pure-tone audiometry","Speech audiometry","audiometric threshold","speech intelligibility threshold","acoustic reflex threshold","NOT_YET_RECRUITING","2026-05-15",{"date":111,"type":112},"2026-05-22","ACTUAL",{"date":109,"type":90},{"date":115,"type":90},"2028-02-15",{"name":5,"class":6},1]