Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FATIGAUDIT)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUniversity Hospital, Montpellier

About this trial

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

Eligibility criteria

Qualifiers

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)

Disqualifiers

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

Trial design

Treatments tested in this trial

  • 2h30 of noise exposure at 85 dB(A)
  • 2 noise exposures of 66 minutes
  • 10 noise exposure cycles
  • No noise exposure

Treatment groups

40 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

National Research Agency, France

Collaborator