MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
MIRACLE
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 20, 2024
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
March 3, 2025
February 1, 2025
1.6 years
May 14, 2024
February 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
percentage of environmental sound cues correctly identified when presented simultaneously with other signals
2 years
Secondary Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Participants with cochlear implant
EXPERIMENTALNormal hearing participants
ACTIVE COMPARATORInterventions
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).
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.
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.
Eligibility Criteria
You may qualify if:
- For all participants:
- 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)
You may not qualify if:
- Be under guardianship or curatorship,
- deprived of liberty by judicial or administrative decision, or subject to legal protection,
- Non- native French speaker.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Pasteurlead
- Institut de l'Auditioncollaborator
Study Sites (1)
CEntre de Recherche et d'Innovation en Audiologie Humaine
Paris, 75015, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 20, 2024
Study Start
March 1, 2025
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
March 3, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share