Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study

Cochlear Prosthesis Implantation Clinical Trial

— RECOVER  

Official title:

Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078763
• Other study ID #: 69HCL19_0238
• Status: Completed
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: September 4, 2020

Study information

• Verified date: November 2020
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cochlear Prosthesis Implantation

Intervention

Behavioral:
• Rehabilitation 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
• Rehabilitation 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.
• SPHERE 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
• French 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.
• Speech 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.

Locations

Country	Name	City	State
France	Hôpital Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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	6 weeks after inclusion
Secondary	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	10 to 12 weeks after inclusion
Secondary	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.	2 weeks after inclusion
Secondary	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	4 weeks after inclusion
Secondary	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	6 weeks after inclusion
Secondary	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	10 to 12 weeks after inclusion