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

NCT07604077 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-22

No results posted yet for this study

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

Conditions

  • D001305
  • Auditory Fatigue
  • Noise Exposure
  • Environmental Noise
  • Auditory Performance

Interventions

OTHER

No noise exposure

No exposure to noise: subjects spend 2H30 in a soundproof cabin.

OTHER

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

OTHER

10 noise exposure cycles

Exposure to 10 cycles of (13 minutes of noise at 85.6 dB(A) / 2 minutes of rest)

OTHER

2h30 of noise exposure at 85 dB(A)

2h30 of uninterrupted noise exposure at 85 dB(A)

Sponsors & Collaborators

  • National Research Agency, France

    collaborator OTHER
  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Renan TARGHETTA · University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2027-05-15
Completion
2028-02-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07604077 on ClinicalTrials.gov