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

Not Applicable

Completed

• Conditions: Cochlear Prosthesis Implantation
• Interventions: Behavioral: Rehabilitation protocol with visual-auditory feedback; Behavioral: Rehabilitation protocol with visual feedback; Behavioral: SPHERE protocol; Behavioral: French Matrix Test; Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire

• Registration Number: NCT04078763
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Study Start: 2019-10-25
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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Exclusion Criteria

• Oculomotor disorder
• Bilateral vestibular areflexia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
visual-auditory feedback	French Matrix Test	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
visual-auditory feedback	Rehabilitation protocol with visual-auditory feedback	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
visual-auditory feedback	SPHERE protocol	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
visual-auditory feedback	Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire	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
visual feedback	Rehabilitation protocol with visual feedback	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
visual feedback	SPHERE protocol	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
visual feedback	French Matrix Test	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
visual feedback	Speech Spatial and Qualities of Hearing Scale (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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
Short term feedback effect on spatial auditory performance	6 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 8 rehabilitation sessions
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
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

Trial Locations

Locations (1)

Hôpital Edouard Herriot; 🇫🇷 Lyon, France