NCT04078763

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cochlear Prosthesis Implantation

Interventions

Type	Name	Description
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
BEHAVIORAL	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.
BEHAVIORAL	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
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2019-10-25
• Primary completion: 2020-09-04
• Completion: 2020-09-04
• First posted: 2019-09-06
• Last updated: 2025-09-04

Locations

1 site across 1 country: France