MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

Cochlear Hearing Loss Clinical Trial

— MIRACLE  

Official title:

MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420921
• Other study ID #: 2023-153
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2026

Study information

• Verified date: April 2024
• Source: Institut Pasteur
• Contact: Clément Gaultier, PhD
• Phone: 0176535126
• Email: clement.gaultier[@]pasteur.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cochlear Hearing Loss
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

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).
• 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.
• 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.

Locations

Country	Name	City	State
France	CEntre de Recherche et d'Innovation en Audiologie Humaine	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Institut Pasteur	Institut de l'Audition

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of environmental sound cues correctly identified when presented simultaneously with other signals		2 years
Secondary	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
Secondary	the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies		2 years
Secondary	percentages of words correctly repeated by participants using personalised speech enhancement strategies		2 years
Secondary	comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off		2 years
Secondary	percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies		2 years
Secondary	percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies		2 years
Secondary	comparison of percentages of words correctly repeated		2 years