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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06420921
Other study ID # 2023-153
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2024
Est. completion date July 2026

Study information

Verified date April 2024
Source Institut Pasteur
Contact Clément Gaultier, PhD
Phone 0176535126
Email clement.gaultier@pasteur.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date July 2026
Est. primary completion date July 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
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).
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.
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.

Locations

Country Name City State
France CEntre de Recherche et d'Innovation en Audiologie Humaine Paris

Sponsors (2)

Lead Sponsor Collaborator
Institut Pasteur Institut de l'Audition

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentage of environmental sound cues correctly identified when presented simultaneously with other signals 2 years
Secondary comparison of the percentages of correctly identified environmental sound cues obtained objectively and deduced from the signal-to-noise ratio corresponding to the trade-off indicated by the participant 2 years
Secondary the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies 2 years
Secondary percentages of words correctly repeated by participants using personalised speech enhancement strategies 2 years
Secondary comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off 2 years
Secondary percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies 2 years
Secondary percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies 2 years
Secondary comparison of percentages of words correctly repeated 2 years
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