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NCT Number: NCT06420921

MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

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.

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Key information

Conditions

Cochlear Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CEntre de Recherche et d'Innovation en Audiologie Humaine

Paris, 75015, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Speech in noise comprehension test

Behavioral

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).

Objective tests of perception of ambient sound cues in noise

Behavioral

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.

Subjective tests of perception of ambient sound cues in noise

Behavioral

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.

Primary outcomes

  1. percentage of environmental sound cues correctly identified when presented simultaneously with other signals

    Time frame: 2 years

Secondary outcomes

  1. 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

    Time frame: 2 years

  2. the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies

    Time frame: 2 years

  3. percentages of words correctly repeated by participants using personalised speech enhancement strategies

    Time frame: 2 years

  4. comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off

    Time frame: 2 years

  5. percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies

    Time frame: 2 years

  6. percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies

    Time frame: 2 years

  7. comparison of percentages of words correctly repeated

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Clément Gaultier, PhD

CONTACT

[email protected]

0176535126 ext. +33

Paul Avan, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Collaborators

  • Institut de l'Audition

Registry information

Acronym: MIRACLE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2024
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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