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

Auditory Perception Clinical Trial

— COMPRESSED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06264245
• Other study ID #: 2022-126
• Secondary ID: 2023-A00985-40
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: May 2024
• Source: Institut Pasteur
• Contact: Céline Quinsac, PhD
• Phone: +33 (0)1 76 53 50 29
• Email: celine.quinsac[@]pasteur.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 15, 2025
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Auditory Perception

Intervention

Other:
• Audiological profile
Video otoscopy Tympanometry High-frequency tonal audiometry
• 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
• 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
• 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.

Locations

Country	Name	City	State
Belgium	Haute Ecole Léonard De Vinci	Bruxelles
France	CEntre de Recherche et d'Innovation en Audiologie Humaine	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur	Institut de l'Audition

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Audiometric thresholds in pure tone from 125 to 8000 Hz in the subject's exposed ear before and approximately one hour after exposure,	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
Secondary	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.	A contralateral noise is a low-pass filtered white noise with a cut-off at 3 kHz.	2 weeks
Secondary	Levels of otoemissions in acoustic distortion products in the exposed ear in response to pure tone sound stimuli	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
Secondary	Tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure.	Measurement of the difference in the perception of tinnitus or auditory distortion (hyperacusis) reported by participants before and after exposure.	2 weeks
Secondary	Effectiveness of the protective auditory reflexes (or acoustic reflexes), obtained by impedancemetry and derived from the reading of the otoemissions for each participant.	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