Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FAT… (NCT07604077) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FATIGAUDIT)
France40 participantsStarted 2026-05-15
Plain-language summary
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.
Being a part of a larger project involving fundamental researchers (animal experimentation) and occupational health specialists (investigations at the workplace), this study aims:
* to evaluate how auditory fatigue caused by acute noise exposure in doses tolerated by law impacts auditory and cognitive performances in humans
* to determine the effect of silent breaks proposed by occupational legislation on cognitive functioning
* to issue new recommendations for the protection of workers exposed to noise
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy subjects aged between 18 and 35
* 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
* 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)
* Without history of excessive noise exposure (1-MINUTE NOISE SCREEN ≤4)
Exclusion Criteria:
* History of sudden deafness or tinnitus lasting more than 48 hours
* Conditions likely to affect hearing (tumours of the ear or base of the skull, etc.)
* History of unresolved chronic otitis
* Work in a noisy environment requiring workplace soundproofing or the use of personal protective equipment
* Migraine with or without aura or tension-type headaches (International Headache Society (IHS) classification)
* Pregnant or breastfeeding women or women of childbearing age not using contraception
* Participation in another interventional clinical trial
* A person whose physical and/or psychological health is severely impaired
* Individuals deprived of their legal capacity, or under guardianship or trusteeship
* Persons deprived of liberty (by judicial or administrative decision)
* Not affiliated to a French social security system or not a beneficiary of this system
* Absence written informed consent t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pure-tone audiometry thresholds
Timeframe: End of follow-up period (up to 1 month)
2
Signal-to-noise ratio (SNR) at speech intelligibility threshold in noise
Timeframe: End of follow-up period (up to 1 month)
3
Acoustic distortion products amplitude measured at acoustic reflex threshold
Timeframe: End of follow-up period (up to 1 month)