Cochlear Prosthesis ImplantationRECOVERNCT04078763
Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study
A study testing Rehabilitation protocol with visual-auditory feedback, Rehabilitation protocol with visual feedback and SPHERE protocol in people with Cochlear Prosthesis Implantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
A new Neuro-Immersion system based on virtual reality and 3D motion tracking has been developed recently, allowing to evaluate and record the spatial localization performance of cochlear implant (CI) users. This system allows to highlight localization deficits in three-dimensional space for all CI patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cochlear Prosthesis Implantation
- What is being tested?
- Rehabilitation protocol with visual-auditory feedback, Rehabilitation protocol with visual feedback and SPHERE protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2019to 4 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years inclusive
- Use of the second CI for at least 1 year
- Regular follow-up in the Ear Nose and Throat department of Edouard Herriot Hospital in Lyon
- Post-lingual deafness
- Average voice recognition over 80% with 2 Cochlear Implants
- Normal vision (with or without correction)
- Able to understand the experimental instructions
- Affiliated to a social security scheme
Who cannot join
- Oculomotor disorder
- Bilateral vestibular areflexia
Trial locations and contacts
1 site in 1 country.
About this study
A new Neuro-Immersion system based on virtual reality and 3D motion tracking has been developed recently, allowing to evaluate and record the spatial localization performance of cochlear implant (CI) users. This system allows to highlight localization deficits in three-dimensional space for all CI patients. Unfortunately, there is currently no suitable postoperative management for these localization problems. However, the discomfort felt by patients is clearly verbalized. Thanks to the new virtual reality system, it is now possible to develop a rehabilitation protocol adapted to each patient. This project will focus on the evaluation of a spatial auditory rehabilitation, based on unisensory (visual) or multisensory (auditory and visual) feedback, for bilateral CI adults.
- Conditions
- Cochlear Prosthesis Implantation
- Being tested
- Rehabilitation protocol with visual-auditory feedback, Rehabilitation protocol with visual feedback, SPHERE protocol, French Matrix Test, Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire
- Keywords
- Spatial hearing perception, cochlear prosthesis implantation users, virtual reality, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation protocol with visual-auditory feedbackBehavioural
The rehabilitation protocol with visual-auditory feedback is based on 8 sessions, over a period of 1 month, with 2 sessions per week. Each session lasts 45 minutes. During a session, the participant has to localize a sound around him, at hand. For this, he has to direct his head (which acts as a pointer) to the place where he seems to get the sound. Then, he validates his answer using the joystick placed in his hand. Regardless of the answer given (exact or incorrect), the subject will always have a visual-auditory feedback
Rehabilitation protocol with visual feedbackBehavioural
The rehabilitation protocol with visual feedback is based on 8 sessions, over a period of 1 month, with 2 sessions per week. Each session lasts 45 minutes. During a session, the participant has to localize a sound around him, at hand. For this, he has to direct his head (which acts as a pointer) to the place where he seems to get the sound. Then, he validates his answer using the joystick placed in his hand. Regardless of the answer given (exact or incorrect), the subject will only have a visual feedback.
SPHERE protocolBehavioural
Data from spatial sound perception will be recorded in three dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error "3d-D", hence summarizing all three space dimensions, and taking into account absolute and variable error in one measure. This lasts 10 minutes and the result is expressed by the 3d-D value
French Matrix TestBehavioural
This test assesses the intelligibility threshold defined as the noise level (in decibels) for which the subject can repeat 50% of the words heard (in dichotic listening), resulting in an Speech Recognition Threshold (SRT) value. This test lasts 10 minutes.
Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaireBehavioural
15 items questionnaire (each answer to questions is quoted between 0 and 10) resulting in a global SSQ 15 score. It takes 10 minutes to fill the questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| visual-auditory feedback | Experimental | Patients included in this arm will follow the rehabilitation protocol with visual-auditory feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire Receives: Behavioral: Rehabilitation protocol with visual-auditory feedback; Behavioral: SPHERE protocol; Behavioral: French Matrix Test; Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire |
| visual feedback | Experimental | Patients included in this arm will follow the rehabilitation protocol with visual feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire Receives: Behavioral: Rehabilitation protocol with visual feedback; Behavioral: SPHERE protocol; Behavioral: French Matrix Test; Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short term rehabilitation effect on the spatial auditory performance - 4 sessions
This effect will be defined as any change in auditory performance scores (3d-D value OR SRT value or SSQ15 questionnaire score) between baseline (before rehabilitation starts) and short term rehabilitation (4 rehabilitation sessions)
Measured: 4 weeks after inclusion
Short term rehabilitation effect on the spatial auditory performance - 8 sessions
This effect will be defined as any change in auditory performance scores (3d-D value OR SRT value or SSQ15 questionnaire score) between baseline (before rehabilitation starts) and short term rehabilitation (8 rehabilitation sessions)
Measured: 6 weeks after inclusion
Secondary outcomes (6)
Percentage of sessions performed on all the rehabilitation sessions during the protocol
compliance of participant to attend the rehabilitation sessions will be measured by calculating the percentage of sessions performed on all the rehabilitation sessions during the protocol
Measured: 6 weeks after inclusion
Middle term rehabilitation effect on the spatial auditory performance
This effect will be defined as any change in auditory performance scores (3d-D value or SRT value or SSQ15 questionnaire score) between baseline (before rehabilitation starts) and 8 to 10 weeks after the first rehabilitation session
Measured: 10 to 12 weeks after inclusion
Measure of auditory performance tests own effect
This effect corresponds to the difference between auditory performance scores (3d-D value, SRT value and SSQ15 questionnaire score) at inclusion and 2 weeks after inclusion, before rehabilitation starts.
Measured: 2 weeks after inclusion
Short term feedback effect on spatial auditory performance
The short term feedback effect on spatial auditory performance will be assessed by comparing the auditory performance scores (3d-D value, SRT value and SSQ15 questionnaire score) of the two groups after 4 rehabilitation sessions
Measured: 4 weeks after inclusion
Short term feedback effect on spatial auditory performance
The short term feedback effect on spatial auditory performance will be assessed by comparing the auditory performance scores (3d-D value, SRT value and SSQ15 questionnaire score) of the two groups after 8 rehabilitation sessions
Measured: 6 weeks after inclusion
Middle term feedback effect on spatial auditory performance
The middle term feedback effect on spatial auditory performance will be assessed by comparing the auditory performance scores (3d-D value, SRT value and SSQ15 questionnaire score) of the two groups 8 to 10 weeks after the first rehabilitation session
Measured: 10 to 12 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start25 Oct 2019
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cochlear Prosthesis ImplantationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric TRUY, Professor, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078763
- Sponsor's protocol ID
- 69HCL19_0238
- Acronym
- RECOVER
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2019
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
PubMed 35943235
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study
- ClinicalTrials.gov ID
- NCT04078763
- Acronym / sponsor ID
- RECOVER / 69HCL19_0238
- Conditions
- Cochlear Prosthesis Implantation
- Keywords
- Spatial hearing perception, cochlear prosthesis implantation users, virtual reality, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 6 Sep 2019 (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.
A new Neuro-Immersion system based on virtual reality and 3D motion tracking has been developed recently, allowing to evaluate and record the spatial localization performance of cochlear implant (CI) users. This system allows to highlight localization deficits in three-dimensional space for all CI patients. Unfortunately, there is currently no suitable postoperative management for these localization problems. However, the discomfort felt by patients is clearly verbalized. Thanks to the new virtual reality system, it is now possible to develop a rehabilitation protocol adapted to each patient. This project will focus on the evaluation of a spatial auditory rehabilitation, based on unisensory (visual) or multisensory (auditory and visual) feedback, for bilateral CI adults.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| visual-auditory feedback | Experimental | Behavioral: Rehabilitation protocol with visual-auditory feedback, Behavioral: SPHERE protocol, Behavioral: French Matrix Test, Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnairePatients included in this arm will follow the rehabilitation protocol with visual-auditory feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire |
| visual feedback | Experimental | Behavioral: Rehabilitation protocol with visual feedback, Behavioral: SPHERE protocol, Behavioral: French Matrix Test, Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnairePatients included in this arm will follow the rehabilitation protocol with visual feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 75 years inclusive
- Use of the second CI for at least 1 year
- Regular follow-up in the Ear Nose and Throat department of Edouard Herriot Hospital in Lyon
- Post-lingual deafness
- Average voice recognition over 80% with 2 Cochlear Implants
Key exclusion criteria (2 listed)
- Oculomotor disorder
- Bilateral vestibular areflexia
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 |
|---|---|---|
| Rehabilitation protocol with visual-auditory feedbackThe rehabilitation protocol with visual-auditory feedback is based on 8 sessions, over a period of 1 month, with 2 sessions per week. Each session lasts 45 minutes. During a session, the participant has to localize a sound around him, at hand. For this, he has to direct his head (which acts as a pointer) to the place where he seems to get the sound. Then, he validates his answer using the joystick placed in his hand. Regardless of the answer given (exact or incorrect), the subject will always have a visual-auditory feedback | Behavioural | visual-auditory feedback |
| Rehabilitation protocol with visual feedbackThe rehabilitation protocol with visual feedback is based on 8 sessions, over a period of 1 month, with 2 sessions per week. Each session lasts 45 minutes. During a session, the participant has to localize a sound around him, at hand. For this, he has to direct his head (which acts as a pointer) to the place where he seems to get the sound. Then, he validates his answer using the joystick placed in his hand. Regardless of the answer given (exact or incorrect), the subject will only have a visual feedback. | Behavioural | visual feedback |
| SPHERE protocolData from spatial sound perception will be recorded in three dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error "3d-D", hence summarizing all three space dimensions, and taking into account absolute and variable error in one measure. This lasts 10 minutes and the result is expressed by the 3d-D value | Behavioural | visual feedback, visual-auditory feedback |
| French Matrix TestThis test assesses the intelligibility threshold defined as the noise level (in decibels) for which the subject can repeat 50% of the words heard (in dichotic listening), resulting in an Speech Recognition Threshold (SRT) value. This test lasts 10 minutes. | Behavioural | visual feedback, visual-auditory feedback |
| Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire15 items questionnaire (each answer to questions is quoted between 0 and 10) resulting in a global SSQ 15 score. It takes 10 minutes to fill the questionnaire. | Behavioural | visual feedback, visual-auditory feedback |
Primary outcome
Short term rehabilitation effect on the spatial auditory performance - 4 sessions
Time frame: 4 weeks after inclusion
This effect will be defined as any change in auditory performance scores (3d-D value OR SRT value or SSQ15 questionnaire score) between baseline (before rehabilitation starts) and short term rehabilitation (4 rehabilitation sessions)
Short term rehabilitation effect on the spatial auditory performance - 8 sessions
Time frame: 6 weeks after inclusion
This effect will be defined as any change in auditory performance scores (3d-D value OR SRT value or SSQ15 questionnaire score) between baseline (before rehabilitation starts) and short term rehabilitation (8 rehabilitation sessions)
6 secondary outcomes
Percentage of sessions performed on all the rehabilitation sessions during the protocol
Time frame: 6 weeks after inclusion
Middle term rehabilitation effect on the spatial auditory performance
Time frame: 10 to 12 weeks after inclusion
Measure of auditory performance tests own effect
Time frame: 2 weeks after inclusion
Short term feedback effect on spatial auditory performance
Time frame: 4 weeks after inclusion
Short term feedback effect on spatial auditory performance
Time frame: 6 weeks after inclusion
Middle term feedback effect on spatial auditory performance
Time frame: 10 to 12 weeks after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 35943235Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
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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. This study is not recruiting at the moment.
Eric TRUY, Professor principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation protocol with visual-auditory feedback, Rehabilitation protocol with visual feedback and SPHERE protocol in people with Cochlear Prosthesis Implantation, run by Hospices Civils de Lyon 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 8 inclusion and 2 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: finished, as of the sponsor's last update on 4 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short term rehabilitation effect on the spatial auditory performance - 4 sessions (time frame: 4 weeks after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078763, which also lists 1 linked publication.
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 4 Sep 2025.