- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06264245
Users of Remote Conferencing and Compression of Sound Dynamics : Auditory Effects (COMPRESSED)
The COMPRESSED project is a descriptive, bi-centric and non-invasive study carried out by the CERIAH - IDA - Institut Pasteur and the Haute École Léonard de Vinci in Brussels on volunteer participants identified in two groups :
- be subject to high exposure to compressed sound, as defined by professional participation in events on broadcast platforms using sound signal processing systems, over the last 3 years,
- be subject to moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student following certain distance learning courses. on a videoconferencing platform, alternating with other face-to-face courses, with the ability to listen during breaks, which have been taught for a maximum of 2 years.
The main objective of the COMPRESSED study is to evaluate the auditory effects of exposure to manipulated sounds (compression, filtering, equalisation, accentuation, etc.) from sound distribution platforms on the auditory system of participants who are regularly exposed to these sounds as a result of their professional activity.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Paul Avan, MD
- Phone Number: +33 (0)1 76 53 50 94
- Email: paul.avan@uca.fr
Study Contact Backup
- Name: Céline Quinsac, PhD
- Phone Number: +33 (0)1 76 53 50 29
- Email: celine.quinsac@pasteur.fr
Study Locations
-
-
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Bruxelles, Belgium
- Not yet recruiting
- Haute Ecole Léonard De Vinci
-
Contact:
- Patrick Vereheyden, MD
- Phone Number: + 32 2 793 41 43
- Email: Patrick.Verheyden@vinci.be
-
-
-
-
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Paris, France, 75015
- Recruiting
- CEntre de Recherche et d'Innovation en Audiologie Humaine
-
Contact:
- Paul Avan, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
For all participants:
- Age 18 or over,
- Work with platforms using sound signal processing systems,
- Fluent in English,
- Fluent in French,
- Declare that they have no hearing loss.
For participants in the high exposure group:
- Have had a professional activity over the last three years using broadcasting platforms with sound signal processing systems,
For participants in the moderate or limited exposure group:
- Have worked between one semester and two years with platforms using sound signal processing systems.
Exclusion Criteria:
- Conductive or mixed hearing loss, i.e. where the hearing loss affects both the outer and/or middle ear and the inner ear.
- Have an asymmetric hearing loss, i.e. a difference in average hearing loss between the left and right ear of more than 20 dB,
- Have a history of otitis and/or an ENT disease that permanently affects hearing (vestibular schwannoma, Ménière's disease, sudden or fluctuating deafness, congenital hypoacusis),
- Not fluent in English
- Be under guardianship,
- Deprived of liberty by judicial or administrative decision, or subject to legal protection.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
High exposure to compressed sound
|
Video otoscopy Tympanometry High-frequency tonal audiometry
Hearing skills questionnaire Subjective assessment of tinnitus using a visual analogue scale Self-questionnaire on the impact of tinnitus Hyperacusis self-questionnaire
Acoustic Omission Measurement of the stapedial reflex by tympanometry High-frequency tonal audiometry - exposed ear only Speech audiometry in noise Tinnitus and subjective discomfort thresholds Psychoacoustic intensity perception test
A self-assessment of the sound quality of the manipulated sounds heard during the exhibition will be carried out during the second follow-up visit.
The elements on which the participant will be asked to make a qualitative judgement will relate to intelligibility difficulties or not; background noise (these two items in the form of a mark between 0 and 10); the clear, muffled or shrill nature of the sounds, their resonant or saturated side.
|
|
Moderate or limited exposure to compressed sound
|
Video otoscopy Tympanometry High-frequency tonal audiometry
Hearing skills questionnaire Subjective assessment of tinnitus using a visual analogue scale Self-questionnaire on the impact of tinnitus Hyperacusis self-questionnaire
Acoustic Omission Measurement of the stapedial reflex by tympanometry High-frequency tonal audiometry - exposed ear only Speech audiometry in noise Tinnitus and subjective discomfort thresholds Psychoacoustic intensity perception test
A self-assessment of the sound quality of the manipulated sounds heard during the exhibition will be carried out during the second follow-up visit.
The elements on which the participant will be asked to make a qualitative judgement will relate to intelligibility difficulties or not; background noise (these two items in the form of a mark between 0 and 10); the clear, muffled or shrill nature of the sounds, their resonant or saturated side.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hearing assessments of participants exposed to manipulated sounds after and before exposure
Time Frame: 2 weeks
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Measurement of the difference between the hearing assessments of participants exposed to manipulated sounds after and before exposure
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Audiometric thresholds in pure tone from 125 to 8000 Hz in the subject's exposed ear before and approximately one hour after exposure,
Time Frame: 2 weeks
|
Measurement of the difference between audiometric thresholds in pure tone from 125 to 8000 Hz in the subject's exposed ear before and approximately one hour after exposure,
|
2 weeks
|
|
Difference between the threshold of the protective reflex of the auditory pathways (middle ear muscles) measured by impedancemetry in the exposed ear when a contralateral noise is presented for a few seconds.
Time Frame: 2 weeks
|
A contralateral noise is a low-pass filtered white noise with a cut-off at 3 kHz.
|
2 weeks
|
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Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli
Time Frame: 2 weeks
|
Comparison of the levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli at 65 dB SPL around 1, 2, 3 and 4 kHz, before and approximately one hour after exposure.
|
2 weeks
|
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Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure.
Time Frame: 2 weeks
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Measurement of the difference in the perception of tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure.
|
2 weeks
|
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Effectiveness of the protective auditory reflexes (or acoustic reflexes), obtained by impedancemetry and derived from the reading of the otoemissions for each participant.
Time Frame: 2 weeks
|
Measurement of the difference of the effectiveness of the protective auditory reflexes (or acoustic reflexes), obtained by impedancemetry and derived from the reading of the otoemissions for each participant.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paul Avan, MD, CeRIAH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022-126
- 2023-A00985-40 (Other Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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