MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE (MIRACLE)

Pasteur Institute

Status: Not yet enrolling

Conditions: Cochlear Hearing Loss

Treatments: Behavioral: Objective tests of perception of ambient sound cues in noise; Behavioral: Subjective tests of perception of ambient sound cues in noise; Behavioral: Speech in noise comprehension test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06420921

2023-153

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Participants with cochlear implant

Experimental group

Treatment:

Behavioral: Speech in noise comprehension test

Behavioral: Subjective tests of perception of ambient sound cues in noise

Behavioral: Objective tests of perception of ambient sound cues in noise

Normal hearing participants

Active Comparator group

Treatment:

Behavioral: Speech in noise comprehension test

Behavioral: Subjective tests of perception of ambient sound cues in noise

Behavioral: Objective tests of perception of ambient sound cues in noise