Cochlear Prosthesis Implantation
Conditions
Keywords
Spatial hearing perception, cochlear prosthesis implantation users, virtual reality, rehabilitation
Brief 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. 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.
Interventions
BEHAVIORALRehabilitation protocol with visual-auditory feedback
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
BEHAVIORALRehabilitation protocol with visual feedback
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.
BEHAVIORALSPHERE protocol
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
BEHAVIORALFrench Matrix Test
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.
BEHAVIORALSpeech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Oculomotor disorder * Bilateral vestibular areflexia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short term rehabilitation effect on the spatial auditory performance - 4 sessions | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of auditory performance tests own effect | 2 weeks after inclusion | 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. |
| Percentage of sessions performed on all the rehabilitation sessions during the protocol | 6 weeks after inclusion | 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 |
| Middle term feedback effect on spatial auditory performance | 10 to 12 weeks after inclusion | 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 |
| Short term feedback effect on spatial auditory performance | 4 weeks after inclusion | 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 |
| Middle term rehabilitation effect on the spatial auditory performance | 10 to 12 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 8 to 10 weeks after the first rehabilitation session |
Countries
France
Outcome results
None listed