Trial · NCT07604077
Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FATIGAUDIT)
NCT07604077, Not applicable, Not yet recruiting, University Hospital, Montpellier
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FATIGAUDIT). Trials, record NCT07604077. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07604077
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fatigue and Hearing Performance of Healthy Volunteers Acutely Exposed to Occupational Noise ( FATIGAUDIT)
- NCT number
- NCT07604077
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 40 participants, estimated
- Lead sponsor
- University Hospital, Montpellier
- Conditions
- D001305, Auditory Fatigue, Noise Exposure, Environmental Noise, Auditory Performance
- Interventions
- 2h30 of noise exposure at 85 dB(A), 2 noise exposures of 66 minutes, 10 noise exposure cycles, No noise exposure
- First posted
- 2026-05-22
- Last updated
- 2026-05-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pure-tone audiometry thresholds | 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 |
| Primary | Signal-to-noise ratio (SNR) at speech intelligibility threshold in noise | 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. |
| Primary | Acoustic distortion products amplitude measured at acoustic reflex threshold | 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. |
| Secondary | Stroop test to assess cognitive load | End of follow-up period (up to 1 month) for all subjects included in the study | 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. |
| Secondary | Baseline tone audiometry | Up to 1 month, for subjects included in experimental groups (1, 2 and 3) | 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. |
| Secondary | Assessment of speech perception in noise | Up to 1 month, for all subjects included in the study | 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. |
| Secondary | Assessment of Acoustic Distortion Products (ADP) | Up to 1 month, for all subjects included in the study | 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. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Stroop Color-Word Test | Secondary outcome |
Source ConductCognition
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07604077
GET https://conductscience.org/api/trials/v1/NCT07604077/registered