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NCT Number: NCT06264245

Users of Remote Conferencing and Compression of Sound Dynamics : Auditory Effects

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haute Ecole Léonard De Vinci, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Audiological profile

Other

Video otoscopy Tympanometry High-frequency tonal audiometry

Hearing self-assessments

Other

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

Objective and subjective audiological tests

Other

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

Self-assessment of exposure sound quality

Other

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.

Primary outcomes

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

    Time frame: 2 weeks

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

Secondary outcomes

  1. 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. 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.

  3. 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.

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

    Time frame: 2 weeks

    Measurement of the difference in the perception of tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Céline Quinsac, PhD

CONTACT

[email protected]

+33 (0)1 76 53 50 29

Paul Avan, MD

CONTACT

[email protected]

+33 (0)1 76 53 50 94

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Institut de l'Audition

Registry information

Acronym: COMPRESSED

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 16, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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