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Recruiting NCT06264245

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

Observational Auditory Perception

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Audiological profile, Hearing self-assessments, Objective and subjective audiological tests, Self-assessment of exposure sound quality.
Who it may be relevant to
Registry conditions: Auditory Perception. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Audiological profile
    Video otoscopy Tympanometry High-frequency tonal audiometry
  • Other Hearing self-assessments
    Hearing skills questionnaire Subjective assessment of tinnitus using a visual analogue scale Self-questionnaire on the impact of tinnitus Hyperacusis self-questionnaire
  • Other Objective and subjective audiological tests
    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
  • Other Self-assessment of exposure sound quality
    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 outcome measures

  • Hearing assessments of participants exposed to manipulated sounds after and before exposure [Time frame: 2 weeks]
Secondary outcome measures (5)
  • 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]
  • 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]
  • Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli [Time frame: 2 weeks]
  • Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure. [Time frame: 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. [Time frame: 2 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Haute Ecole Léonard De Vinci — Brussels
France · 1 center
  • CEntre de Recherche et d'Innovation en Audiologie Humaine — Paris

Identifiers

NCT: NCT06264245 · 2022-126 · 2023-A00985-40

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗