D001305FATIGAUDITNCT07604077
Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FATIGAUDIT)
A study testing 2h30 of noise exposure at 85 dB(A), 2 noise exposures of 66 minutes and 10 noise exposure cycles in people with D001305 and Auditory Fatigue, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- D001305, Auditory Fatigue, Noise Exposure
- What is being tested?
- 2h30 of noise exposure at 85 dB(A), 2 noise exposures of 66 minutes and 10 noise exposure cycles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 15 May 2026to 15 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Akil KADERBAY, Dr contact
France1 site
CHU Gui de Chauliac, ENT & Head and Neck Surgery Department
Montpellier
About this study
Official title: Fatigue and Hearing Performance in Healthy, Normal-hearing Volunteers Acutely Exposed to Occupational Noise Not Requiring Personal Protection. FATIGAUDIT
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
Read the detailed description
Study rationale:
Individuals routinely endure daily noise exposure related to transportation as well as occupational and recreational (portable music players, video games, concerts) activities. European and United States regulations have limited occupational noise exposure to 85 dB(A) (A-weighting - the sound pressure level filtered appropriately to the human audiogram) based on an 8h working day. This level is commonly encountered in the manufacturing, construction, and music industries, while noise levels are constantly increasing in the tertiary sector.
Overall, 13% of people are exposed to a cumulative daily dose of noise equal to or exceeding 85 dB(A) approved by law. This is not without a harm: excessive noise exposure rises stress levels, induces physical tiredness and causes headaches leading to increased workplace accident rates. It can also stimulate aggression and other antisocial behaviours.
Importantly, a daily noise exposure of 85 dB(A) is responsible for "auditory fatigue" - a complex phenomenon correlated to a temporary elevation of hearing thresholds or TTS (temporary threshold shift). According to recent investigations, daily TTS can reach 5 dB elevations (i.e. a 68% decrease in sound intensity perceived) in factory workers and sound engineers at the end of every single workday.
Auditory fatigue has received little attention in the scientific literature because TTS is considered fully reversible and therefore inoffensive. This complacency might be misplaced: auditory fatigue repeated throughout a career may contribute to:
- the permanent hearing loss experienced by 10-15% of people exposed to occupational noise below the legal exposure limit
- the increased rate of chronic auditory disorders such as tinnitus (a perception of phantom sounds) or hyperacusis (a reduced tolerance for moderate sound levels) in professional musicians and noise-exposed workers
- a decrease in auditory performance (e.g. speech-in-noise or frequency discrimination), a heavier cognitive load or an adaptive modification of brain circuits under the prolonged sensory constraints of noise masking and degraded hearing sensitivity
Recent rodent studies show that a TTS can have damaging consequences on sensorineural inner ear structures despite a long-term recovery of hearing thresholds. For instance, weeks to months of continuous exposure at 85 dB Sound Pressure Level (SPL) may induce ultrastructural abnormalities within the cochlea, loss of synaptic ribbons in sensory inner hair cells, an amplitude decrease of auditory nerve activity and delayed degeneration of auditory nerve fibres. These symptoms, referred to as synaptopathy, disrupt the signal transmission. This could potentially explain why some subjects experience poor speech perception in noise despite normal auditory thresholds.
Whether auditory fatigue, i.e. the daily noise-induced TTS after 8 hours at 85 dB(A), involves one of the above insults (or other ones) remains unknown. The possibility of preventing auditory fatigue, for example by rest periods, also depends on the mechanisms involved and their kinetics. Due to its fast recovery at the scale of minutes or hours, it is scientifically and technically challenging to detect auditory fatigue and then establish its relationship with immediate- and long-term consequences on the molecular, functional, and perceptive levels. Nevertheless, auditory fatigue is an important and neglected public and occupational health issue.
The aim of the FATIGAUDIT study is:
- to better evaluate the temporary changes in auditory and cognitive performances of healthy volunteers after an acute noise exposure of 85 dB(A) for 2 and a half hours (the sound level in a noisy canteen or during choir rehearsal for a duration well below the legal threshold of 8 hours)
- to determine whether the introduction of silent breaks limits these temporary changes and reduces a cognitive load
From an ethical point of view, it is not possible to propose prolonged and/or chronic exposure to this type of noise as it might damage hearing irreversibly.
- Being tested
- 2h30 of noise exposure at 85 dB(A), 2 noise exposures of 66 minutes, 10 noise exposure cycles, No noise exposure
- Keywords
- Audiometry, pure-tone audiometry, Speech audiometry, audiometric threshold, speech intelligibility threshold, acoustic reflex threshold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2h30 of noise exposure at 85 dB(A)Other
2h30 of uninterrupted noise exposure at 85 dB(A)
2 noise exposures of 66 minutesOther
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
10 noise exposure cyclesOther
Exposure to 10 cycles of (13 minutes of noise at 85.6 dB(A) / 2 minutes of rest)
No noise exposureOther
No exposure to noise: subjects spend 2H30 in a soundproof cabin.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Other: No noise exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: End of follow-up period (up to 1 month)
Secondary outcomes (4)
Stroop test to assess cognitive load
The Stroop test will be used. In the first part of this test, a participant will hear 2 types of pure tones:187 Hz tone or 448 Hz tone, each lasting for 690ms. The choice of a tone perceived ("low"or "high")should be made rapidly by clicking an appropriate category on an electronic support. . 24 stimuli will be randomly presented at a ratio 1:1.
In the second part, the participant will be exposed to the words "Grave" (Low) or "Aigüe" (High) synthetically generated with a low voice (187Hz) or a high voice (448Hz). 4 combinations are possible: "Grave" with a low voice, "Grave" with a high voice, "Aigüe" with a low voice and "Aigüe" with a high voice. 48 stimuli will be presented at a ration 1:1:1:1 and reaction time will be measured.
The Stroop test evaluates modifications in cognitive charge in the groups exposed to noise (1, 2, 3) compared to the control group (4) through the error rate.
Measured: End of follow-up period (up to 1 month) for all subjects included in the study
Baseline tone audiometry
This exam will be 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. It aims to evaluate the perceptive hearing performance of participants in group 1 (exposed to uninterrupted noise) compared to groups 2 and 3.
Measured: Up to 1 month, for subjects included in experimental groups (1, 2 and 3)
Assessment of speech perception in noise
This measure will be done with Speech-in-Noise (SIN) test. The test is conducted in a soundproof booth using TDH-39 headphones, in diotic binaural listening mode. The noise level is set at 73 dB Sound Pressure Level (SPL). To familiarize participants with the task while minimizing learning effects, the session begins with a single practice block of 10 sentences. The sentences are then presented in lists of 10. For each sentence repetition, only key words are scored. Each list tests 9 signal-to-noise ratios (SNRs) ranging from +24 dB to 0 dB in 3 dB steps. The total administration time for the three lists is under 4 minutes. The signal-to-noise ratio at which 50% of the words are correctly repeated is determined.
Measured: Up to 1 month, for all subjects included in the study
Assessment of Acoustic Distortion Products (ADP)
The EchoScan test will be used. Participants will receive auditory stimuli to measure the acoustic distortion product (ADP) generated by inner ear. ADP can be diminished by the middle ear reflex when sounds are delivered at high intensity. Thus, the stimulation intensity is limited to 100dB HL.
This test allows to evaluate cochlear and middle ear functions and determine the acoustic reflex threshold activation which can be affected by auditory fatigue.
Measured: Up to 1 month, for all subjects included in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 May 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for D001305Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 groups of healthy volunteers will be exposed to noise and one group of healthy volunteers will not be exposed
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Renan TARGHETTA, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07604077
- Sponsor's protocol ID
- RECHMPL22_0104
- Other IDs
- 2024-A01702-45
- Acronym
- FATIGAUDIT
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue and Hearing Performance in Healthy, Normal-hearing Volunteers Acutely Exposed to Occupational Noise Not Requiring Personal Protection. FATIGAUDIT
- ClinicalTrials.gov ID
- NCT07604077
- Acronym / sponsor ID
- FATIGAUDIT / RECHMPL22_0104
- Keywords
- Audiometry, pure-tone audiometry, Speech audiometry, audiometric threshold, speech intelligibility threshold, acoustic reflex threshold
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Study rationale:
Individuals routinely endure daily noise exposure related to transportation as well as occupational and recreational (portable music players, video games, concerts) activities. European and United States regulations have limited occupational noise exposure to 85 dB(A) (A-weighting - the sound pressure level filtered appropriately to the human audiogram) based on an 8h working day. This level is commonly encountered in the manufacturing, construction, and music industries, while noise levels are constantly increasing in the tertiary sector.
Overall, 13% of people are exposed to a cumulative daily dose of noise equal to or exceeding 85 dB(A) approved by law. This is not without a harm: excessive noise exposure rises stress levels, induces physical tiredness and causes headaches leading to increased workplace accident rates. It can also stimulate aggression and other antisocial behaviours.
Importantly, a daily noise exposure of 85 dB(A) is responsible for "auditory fatigue" - a complex phenomenon correlated to a temporary elevation of hearing thresholds or TTS (temporary threshold shift). According to recent investigations, daily TTS can reach 5 dB elevations (i.e. a 68% decrease in sound intensity perceived) in factory workers and sound engineers at the end of every single workday.
Auditory fatigue has received little attention in the scientific literature because TTS is considered fully reversible and therefore inoffensive. This complacency might be misplaced: auditory fatigue repeated throughout a career may contribute to:
- the permanent hearing loss experienced by 10-15% of people exposed to occupational noise below the legal exposure limit
- the increased rate of chronic auditory disorders such as tinnitus (a perception of phantom sounds) or hyperacusis (a reduced tolerance for moderate sound levels) in professional musicians and noise-exposed workers
- a decrease in auditory performance (e.g. speech-in-noise or frequency discrimination), a heavier cognitive load or an adaptive modification of brain circuits under the prolonged sensory constraints of noise masking and degraded hearing sensitivity
Recent rodent studies show that a TTS can have damaging consequences on sensorineural inner ear structures despite a long-term recovery of hearing thresholds. For instance, weeks to months of continuous exposure at 85 dB Sound Pressure Level (SPL) may induce ultrastructural abnormalities within the cochlea, loss of synaptic ribbons in sensory inner hair cells, an amplitude decrease of auditory nerve activity and delayed degeneration of auditory nerve fibres. These symptoms, referred to as synaptopathy, disrupt the signal transmission. This could potentially explain why some subjects experience poor speech perception in noise despite normal auditory thresholds.
Whether auditory fatigue, i.e. the daily noise-induced TTS after 8 hours at 85 dB(A), involves one of the above insults (or other ones) remains unknown. The possibility of preventing auditory fatigue, for example by rest periods, also depends on the mechanisms involved and their kinetics. Due to its fast recovery at the scale of minutes or hours, it is scientifically and technically challenging to detect auditory fatigue and then establish its relationship with immediate- and long-term consequences on the molecular, functional, and perceptive levels. Nevertheless, auditory fatigue is an important and neglected public and occupational health issue.
The aim of the FATIGAUDIT study is:
- to better evaluate the temporary changes in auditory and cognitive performances of healthy volunteers after an acute noise exposure of 85 dB(A) for 2 and a half hours (the sound level in a noisy canteen or during choir rehearsal for a duration well below the legal threshold of 8 hours)
- to determine whether the introduction of silent breaks limits these temporary changes and reduces a cognitive load
From an ethical point of view, it is not possible to propose prolonged and/or chronic exposure to this type of noise as it might damage hearing irreversibly.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 3 groups of healthy volunteers will be exposed to noise and one group of healthy volunteers will not be exposed
| Arm | Type | Receives |
|---|---|---|
| Group 1 : 2H30 of non-stop noise exposure | Experimental | Other: 2h30 of noise exposure at 85 dB(A)Group 1 (n=10) will be exposed to 85 dB(A) for 2h30 without any interruption of noise exposure |
| Group 2 : 2 noise exposures of 66 min | Experimental | Other: 2 noise exposures of 66 minutesGroup 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. |
| Group 3 : 10 noise exposure cycles | Experimental | Other: 10 noise exposure cyclesGroup 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. |
| Group 4 : no noise exposure | Other | Other: No noise exposureGroup 4 (n=10) will not be exposed to noise and will serve as a control. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2h30 of noise exposure at 85 dB(A)2h30 of uninterrupted noise exposure at 85 dB(A) | Other | Group 1 : 2H30 of non-stop noise exposure |
| 2 noise exposures of 66 minutesExposure 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 | Group 2 : 2 noise exposures of 66 min |
| 10 noise exposure cyclesExposure to 10 cycles of (13 minutes of noise at 85.6 dB(A) / 2 minutes of rest) | Other | Group 3 : 10 noise exposure cycles |
| No noise exposureNo exposure to noise: subjects spend 2H30 in a soundproof cabin. | Other | Group 4 : no noise exposure |
Primary outcome
Pure-tone audiometry thresholds
Time frame: End of follow-up period (up to 1 month)
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
Signal-to-noise ratio (SNR) at speech intelligibility threshold in noise
Time frame: End of follow-up period (up to 1 month)
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.
Acoustic distortion products amplitude measured at acoustic reflex threshold
Time frame: End of follow-up period (up to 1 month)
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.
4 secondary outcomes
Stroop test to assess cognitive load
Time frame: End of follow-up period (up to 1 month) for all subjects included in the study
Baseline tone audiometry
Time frame: Up to 1 month, for subjects included in experimental groups (1, 2 and 3)
Assessment of speech perception in noise
Time frame: Up to 1 month, for all subjects included in the study
Assessment of Acoustic Distortion Products (ADP)
Time frame: Up to 1 month, for all subjects included in the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Akil KADERBAY, Dr contact
Renan TARGHETTA study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2h30 of noise exposure at 85 dB(A), 2 noise exposures of 66 minutes and 10 noise exposure cycles in people with D001305 and Auditory Fatigue, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michel MONDAIN, Pr (+33 467336893, m-mondain@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure-tone audiometry thresholds (time frame: End of follow-up period (up to 1 month)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.