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MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06420921
Acronym
MIRACLE
Enrollment
50
Registered
2024-05-20
Start date
2025-03-31
Completion date
2026-10-31
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Hearing Loss

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.

Interventions

BEHAVIORALSpeech 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).

BEHAVIORALObjective 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.

BEHAVIORALSubjective 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.

Sponsors

Institut de l'Audition
CollaboratorOTHER
Institut Pasteur
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
percentage of environmental sound cues correctly identified when presented simultaneously with other signals2 years

Secondary

MeasureTime frame
the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies2 years
percentages of words correctly repeated by participants using personalised speech enhancement strategies2 years
comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off2 years
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 participant2 years
percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies2 years
comparison of percentages of words correctly repeated2 years
percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies2 years

Countries

France

Contacts

Primary ContactClément Gaultier, PhD
clement.gaultier@pasteur.fr0176535126
Backup ContactPaul Avan, MD
paul.avan@pasteur.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026