MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

NCT ID: NCT06420921

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-31

Study Completion Date

2026-10-31

Brief Summary

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The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with cochlear implant(s).

The measures and strategies developed in this project could benefit all current and future cochlear implant wearers by improving their perception of the sound environment and their quality of life on a daily basis.

Researchers will compare normal hearing participant and participants with cochlear implant to describe the speech in noise and their perception of the sound environment.

Participants will perform audiological tests to assess their perception of the sound environment, with and without speech enhancement.

Detailed Description

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Conditions

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Cochlear Hearing Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Participants with cochlear implant

Group Type EXPERIMENTAL

Speech in noise comprehension test

Intervention Type BEHAVIORAL

Speech in noise comprehension tests consisting of listening to a speech source and one or more competing sources (noise, speech or sound cues) simultaneously. The volunteers will have to repeat the speech source in order to assess intelligibility for each situation, as a function of the intensity ratio of the two sources (SNR).

Objective tests of perception of ambient sound cues in noise

Intervention Type BEHAVIORAL

Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. The volunteers will have to identify sound cues in order to assess the ability to perceive the sound environment for each situation, depending on the intensity ratio of the different sources.

Subjective tests of perception of ambient sound cues in noise

Intervention Type BEHAVIORAL

Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. Using a simple interface, the volunteers will have to identify the intensity ratio of the sources that they consider to be the best compromise between understanding speech and perceiving the sound environment.

Normal hearing participants

Group Type ACTIVE_COMPARATOR

Speech in noise comprehension test

Intervention Type BEHAVIORAL

Speech in noise comprehension tests consisting of listening to a speech source and one or more competing sources (noise, speech or sound cues) simultaneously. The volunteers will have to repeat the speech source in order to assess intelligibility for each situation, as a function of the intensity ratio of the two sources (SNR).

Objective tests of perception of ambient sound cues in noise

Intervention Type BEHAVIORAL

Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. The volunteers will have to identify sound cues in order to assess the ability to perceive the sound environment for each situation, depending on the intensity ratio of the different sources.

Subjective tests of perception of ambient sound cues in noise

Intervention Type BEHAVIORAL

Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. Using a simple interface, the volunteers will have to identify the intensity ratio of the sources that they consider to be the best compromise between understanding speech and perceiving the sound environment.

Interventions

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Speech in noise comprehension test

Speech in noise comprehension tests consisting of listening to a speech source and one or more competing sources (noise, speech or sound cues) simultaneously. The volunteers will have to repeat the speech source in order to assess intelligibility for each situation, as a function of the intensity ratio of the two sources (SNR).

Intervention Type BEHAVIORAL

Objective tests of perception of ambient sound cues in noise

Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. The volunteers will have to identify sound cues in order to assess the ability to perceive the sound environment for each situation, depending on the intensity ratio of the different sources.

Intervention Type BEHAVIORAL

Subjective tests of perception of ambient sound cues in noise

Tests of perception of the sound environment consisting of listening to a source of noise, sound cues and a competing source of speech simultaneously. Using a simple interface, the volunteers will have to identify the intensity ratio of the sources that they consider to be the best compromise between understanding speech and perceiving the sound environment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

For all participants:

* 18 years of age or over,
* Native French speaker,
* Having given their consent to take part in the research.

For cochlear implant patients:

* Adult implanted and declaring that they have been using the implant for at least 18 months,
* Normal speech audiometry in silence

For controls reporting normal hearing:

* Normal tonal audiometry (defined as a mean tonal loss not exceeding 30 decibel (dB) HL)
* Normal speech audiometry in noise (SNR between -8 dB and -4dB inclusive)

Exclusion Criteria

* Be under guardianship or curatorship,
* deprived of liberty by judicial or administrative decision, or subject to legal protection,
* Non- native French speaker.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut Pasteur

INDUSTRY

Sponsor Role lead

Institut de l'Audition

OTHER

Sponsor Role collaborator

Responsible Party

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Responsibility Role SPONSOR

Locations

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CEntre de Recherche et d'Innovation en Audiologie Humaine

Paris, , France

Site Status

Countries

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France

Central Contacts

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Clément Gaultier, PhD

Role: CONTACT

0176535126 ext. +33

Paul Avan, MD

Role: CONTACT

Other Identifiers

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2023-153

Identifier Type: -

Identifier Source: org_study_id

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