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Not yet recruiting NCT06420921

MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

No phase Interventional Cochlear Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Speech in noise comprehension test, Objective tests of perception of ambient sound cues in noise, Subjective tests of perception of ambient sound cues in noise.
Who it may be relevant to
Registry conditions: Cochlear Hearing Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • 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.

Primary outcome measures

  • percentage of environmental sound cues correctly identified when presented simultaneously with other signals [Time frame: 2 years]
Secondary outcome measures (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 [Time frame: 2 years]
  • the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies [Time frame: 2 years]
  • percentages of words correctly repeated by participants using personalised speech enhancement strategies [Time frame: 2 years]
  • comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off [Time frame: 2 years]
  • percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies [Time frame: 2 years]
  • percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies [Time frame: 2 years]
  • comparison of percentages of words correctly repeated [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • CEntre de Recherche et d'Innovation en Audiologie Humaine — Paris

Identifiers

NCT: NCT06420921 · 2023-153

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗