Cochlear Hearing LossMIRACLENCT06420921
MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
A study testing Speech in noise comprehension test, Objective tests of perception of ambient sound cues in noise and Subjective tests of perception of ambient sound cues in noise in people with Cochlear Hearing Loss, run by Institut Pasteur at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cochlear Hearing Loss
- What is being tested?
- Speech in noise comprehension test, Objective tests of perception of ambient sound cues in noise and Subjective tests of perception of ambient sound cues in noise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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)
Who cannot join
- Be under guardianship or curatorship,
- deprived of liberty by judicial or administrative decision, or subject to legal protection,
- Non- native French speaker.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Avan, MD contact
France1 site
CEntre de Recherche et d'Innovation en Audiologie Humaine
Paris, 75015
About this study
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.
Read more
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.
- Conditions
- Cochlear Hearing Loss
- Being tested
- 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
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech in noise comprehension testBehavioural
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 noiseBehavioural
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 noiseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with cochlear implant | Experimental | Not described Receives: Behavioral: Speech in noise comprehension test; Behavioral: Objective tests of perception of ambient sound cues in noise; Behavioral: Subjective tests of perception of ambient sound cues in noise |
| Normal hearing participants | Active comparator | Not described Receives: Behavioral: Speech in noise comprehension test; Behavioral: Objective tests of perception of ambient sound cues in noise; Behavioral: Subjective tests of perception of ambient sound cues in noise |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of environmental sound cues correctly identified when presented simultaneously with other signals
Measured: 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
Measured: 2 years
the percentages of words correctly repeated by participants using non-personalised speech enhancement strategies
Measured: 2 years
percentages of words correctly repeated by participants using personalised speech enhancement strategies
Measured: 2 years
comparison of the percentages of correctly identified sound cues and the SNR corresponding to the subjective trade-off
Measured: 2 years
percentages of sound cues correctly identified by the participants using non-personalised speech enhancement strategies
Measured: 2 years
percentages of sound cues correctly identified by the participants using personalised speech enhancement strategies
Measured: 2 years
comparison of percentages of words correctly repeated
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study startMar 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Hearing LossStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de l'Audition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420921
- Sponsor's protocol ID
- 2023-153
- Acronym
- MIRACLE
- Status last verified
- Feb 2025
- First submitted
- 14 May 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
- ClinicalTrials.gov ID
- NCT06420921
- Acronym / sponsor ID
- MIRACLE / 2023-153
- Conditions
- Cochlear Hearing Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Institut de l'Audition
- Study start
- Mar 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with cochlear implant | Experimental | Behavioral: Speech in noise comprehension test, Behavioral: Objective tests of perception of ambient sound cues in noise, Behavioral: Subjective tests of perception of ambient sound cues in noise |
| Normal hearing participants | Active comparator | Behavioral: Speech in noise comprehension test, Behavioral: Objective tests of perception of ambient sound cues in noise, Behavioral: Subjective tests of perception of ambient sound cues in noise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age or over,
- Native French speaker,
- Having given their consent to take part in the research.
- Adult implanted and declaring that they have been using the implant for at least 18 months,
- Normal speech audiometry in silence
Key exclusion criteria (3 listed)
- Be under guardianship or curatorship,
- deprived of liberty by judicial or administrative decision, or subject to legal protection,
- Non- native French speaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech in noise comprehension testSpeech 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). | Behavioural | Normal hearing participants, Participants with cochlear implant |
| Objective tests of perception of ambient sound cues in noiseTests 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. | Behavioural | Normal hearing participants, Participants with cochlear implant |
| Subjective tests of perception of ambient sound cues in noiseTests 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. | Behavioural | Normal hearing participants, Participants with cochlear implant |
Primary outcome
percentage of environmental sound cues correctly identified when presented simultaneously with other signals
Time frame: 2 years
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paul Avan, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech in noise comprehension test, Objective tests of perception of ambient sound cues in noise and Subjective tests of perception of ambient sound cues in noise in people with Cochlear Hearing Loss, run by Institut Pasteur at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clément Gaultier, PhD (0176535126 ext. +33, clement.gaultier@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of environmental sound cues correctly identified when presented simultaneously with other signals (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.