NCT04078763|Completed
Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study
RECOVER
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RECOVER
Sponsor study identifier
interventional
12
1 country
1
Study Start
October 25, 2019
Actual (reported)Primary Completion
September 4, 2020
Actual (reported)Study Completion
September 4, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 4, 2020
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2, 2019
Actual (reported)September 6, 2019
Actual (reported)October 25, 2019
Actual (reported)September 4, 2020
Actual (reported)September 4, 2020
Actual (reported)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)
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)
6 weeks after inclusion
Percentage of sessions performed on all the rehabilitation sessions during the protocol
6 weeks after inclusion
Middle term rehabilitation effect on the spatial auditory performance
10 to 12 weeks after inclusion
Measure of auditory performance tests own effect
2 weeks after inclusion
Short term feedback effect on spatial auditory performance
4 weeks after inclusion
Short term feedback effect on spatial auditory performance
6 weeks after inclusion
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
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
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
Hôpital Edouard Herriot
Lyon, 69003, France
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.
Eric TRUY, Professor
Hospices Civils de Lyon
12 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2019
First Posted
September 6, 2019
Study Start
October 25, 2019
Actual (reported)Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System
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.
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
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.
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.
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Primary Completion
September 4, 2020
Actual (reported)Study Completion
September 4, 2020
Actual (reported)Last Updated
September 4, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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