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

NCT07604077 | Not Yet Recruiting

• 2 other identifiers: RECHMPL22_01042024-A01702-45
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Audiometry; pure-tone audiometry; Speech audiometry; audiometric threshold; speech intelligibility threshold; acoustic reflex threshold

Outcome Measures

Primary Outcomes (3)

• Pure-tone audiometry thresholds

  Variations in perceptive auditory performance related to the hearing threshold and the hearing threshold at each frequency will be compared between the experimental groups exposed to noise (1, 2 and 3) and a control group not exposed to noise (4). The exam will allow to determine the participants hearing levels at different frequences line according to Hughson-Westlake's procedure: 125, 250, 500, 1000, 2000, 3000, 4000, 5000, 6000, 8000, 10000, 12500Hz

  End of follow-up period (up to 1 month)

• Signal-to-noise ratio (SNR) at speech intelligibility threshold in noise

  Variations in perceptive auditory performance related to the signal-to-noise ratio of the speech intelligibility threshold in speech audiometry in noise will be compared between the experimental groups exposed to noise (1, 2 and 3) and a control group not exposed to noise (4). The Speech-in-Noise (SIN) test assesses speech intelligibility in noise. It is conducted in a soundproof booth using headphones, with background noise set at 73 dB. After a brief training session, the participant repeats sentences presented at different levels of difficulty (signal-to-noise ratios ranging from +24 to 0 dB). Only key words are taken into account. The result corresponds to the noise level at which 50% of the words are correctly repeated.

  End of follow-up period (up to 1 month)

• Acoustic distortion products amplitude measured at acoustic reflex threshold

  Variations in perceptive auditory performance related to acoustic distortion products amplitude measured at acoustic reflex threshold will be compared between the experimental groups exposed to noise (1, 2 and 3) and a control group not exposed to noise (4). PDA measurement combined with acoustic stimulation can therefore be used to assess the activity of various acoustic reflexes.The ECHOSCAN device automatically determines the reflex threshold by presenting contralateral acoustic stimuli of increasing intensity, each lasting 2 seconds. The stimulus intensity is limited to 100 dB HL.

  End of follow-up period (up to 1 month)

Secondary Outcomes (4)

• Stroop test to assess cognitive load

  End of follow-up period (up to 1 month) for all subjects included in the study

• Baseline tone audiometry

  Up to 1 month, for subjects included in experimental groups (1, 2 and 3)

• Assessment of speech perception in noise

  Up to 1 month, for all subjects included in the study

• Assessment of Acoustic Distortion Products (ADP)

  Up to 1 month, for all subjects included in the study

Study Arms (4)

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

Other: 2h30 of noise exposure at 85 dB(A)

Group 2 : 2 noise exposures of 66 min

EXPERIMENTAL

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.

Other: 2 noise exposures of 66 minutes

Group 3 : 10 noise exposure cycles

EXPERIMENTAL

Group 3 (n=10) will be exposed to 10 cycles of (13 minutes of noise at 85.6 dB(A) / 2 minutes of rest), for a total duration of noise exposure equivalent to 85 dB(A) for 2h30.

Other: 10 noise exposure cycles

Group 4 : no noise exposure

OTHER

Group 4 (n=10) will not be exposed to noise and will serve as a control.

Other: No noise exposure

Interventions

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

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

Group 1 : 2H30 of non-stop noise exposure

2 noise exposures of 66 minutes OTHER

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

Group 2 : 2 noise exposures of 66 min

10 noise exposure cycles OTHER

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

Group 3 : 10 noise exposure cycles

No noise exposure OTHER

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

Group 4 : no noise exposure

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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 to participate in the study

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• National Research Agency, France: collaborator

Study Sites (1)

CHU Gui de Chauliac, ENT & Head and Neck Surgery Department

Montpellier, France

Location

Study Officials

• Renan TARGHETTA

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Michel MONDAIN, Pr

CONTACT

+33 467336893; m-mondain@chu-montpellier.fr

Akil KADERBAY, Dr

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 groups of healthy volunteers will be exposed to noise and one group of healthy volunteers will not be exposed

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 22, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)