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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cochlear Hearing Loss
• Intervention / Treatment: Behavioral: Speech in noise comprehension test; Behavioral: Objective tests of perception of ambient sound cues in noise; Behavioral: Subjective tests of perception of ambient sound cues in noise

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clément Gaultier, PhD; Phone Number: +33 0176535126; Email: clement.gaultier@pasteur.fr
• Study Contact Backup: Name: Paul Avan, MD; Email: paul.avan@pasteur.fr

Study Locations

• France
  • Paris, France, 75015
    • CEntre de Recherche et d'Innovation en Audiologie Humaine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with cochlear implant	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).; 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.; 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.
Active Comparator: Normal hearing participants	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).; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
percentage of environmental sound cues correctly identified when presented simultaneously with other signals	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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
the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies	2 years
percentages of words correctly repeated by participants using personalised speech enhancement strategies	2 years
comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off	2 years
percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies	2 years
percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies	2 years
comparison of percentages of words correctly repeated	2 years

Collaborators and Investigators

• Sponsor: Institut Pasteur
• Collaborators: Institut de l'Audition

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Sensorineural
• Other Study ID Numbers: 2023-153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No