Clinical trial NCT06420921: MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
Official title: MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cochlear Hearing Loss
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Institut de l'Audition
First posted: 2024-05-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: percentage of environmental sound cues correctly identified when presented simultaneously with other signals
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
measure: the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies
timeFrame: 2 years
measure: percentages of words correctly repeated by participants using personalised speech enhancement strategies
timeFrame: 2 years
measure: comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off
timeFrame: 2 years
measure: percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies
timeFrame: 2 years
measure: percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies
timeFrame: 2 years
measure: comparison of percentages of words correctly repeated
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: CEntre de Recherche et d'Innovation en Audiologie Humaine
Study officials:
References: