NCT06264245

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

January 29, 2024

Last Update Submit

February 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hearing assessments of participants exposed to manipulated sounds after and before exposure

    Measurement of the difference between the hearing assessments of participants exposed to manipulated sounds after and before exposure

    2 weeks

Secondary Outcomes (5)

  • 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.

    2 weeks

  • Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli

    2 weeks

  • Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure.

    2 weeks

  • 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

Study Arms (2)

High exposure to compressed sound

Other: Audiological profileOther: Hearing self-assessmentsOther: Objective and subjective audiological testsOther: Self-assessment of exposure sound quality

Moderate or limited exposure to compressed sound

Other: Audiological profileOther: Hearing self-assessmentsOther: Objective and subjective audiological testsOther: Self-assessment of exposure sound quality

Interventions

Video otoscopy Tympanometry High-frequency tonal audiometry

High exposure to compressed soundModerate or limited exposure to compressed sound

Hearing skills questionnaire Subjective assessment of tinnitus using a visual analogue scale Self-questionnaire on the impact of tinnitus Hyperacusis self-questionnaire

High exposure to compressed soundModerate or limited exposure to compressed sound

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

High exposure to compressed soundModerate or limited exposure to compressed sound

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.

High exposure to compressed soundModerate or limited exposure to compressed sound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with sustained exposure to compressed sounds, as defined by professional participation in broadcast platform events using sound signal processing systems, over the last 3 years, Or Subjects with moderate or limited exposure to compressed and manipulated sound, equivalent to that of a student taking distance-learning courses on a videoconferencing platform, alternating with other face-to-face courses, with the possibility of pauses in listening, exposed for a maximum of 2 years.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haute Ecole Léonard De Vinci

Brussels, Belgium

NOT YET RECRUITING

CEntre de Recherche et d'Innovation en Audiologie Humaine

Paris, 75015, France

RECRUITING

Study Officials

  • Paul Avan, MD

    CERIAH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 16, 2024

Study Start

June 1, 2024

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations