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

August 27, 2025 updated by: Hospices Civils de Lyon
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • Hôpital Edouard Herriot

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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: 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.
Experimental: 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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term rehabilitation effect on the spatial auditory performance - 4 sessions
Time Frame: 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)
4 weeks after inclusion
Short term rehabilitation effect on the spatial auditory performance - 8 sessions
Time Frame: 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)
6 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of sessions performed on all the rehabilitation sessions during the protocol
Time Frame: 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
6 weeks after inclusion
Middle term rehabilitation effect on the spatial auditory performance
Time Frame: 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
10 to 12 weeks after inclusion
Measure of auditory performance tests own effect
Time Frame: 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.
2 weeks after inclusion
Short term feedback effect on spatial auditory performance
Time Frame: 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
4 weeks after inclusion
Short term feedback effect on spatial auditory performance
Time Frame: 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
6 weeks after inclusion
Middle term feedback effect on spatial auditory performance
Time Frame: 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
10 to 12 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Eric TRUY, Professor, Hospices civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2019

Primary Completion (Actual)

September 4, 2020

Study Completion (Actual)

September 4, 2020

Study Registration Dates

First Submitted

September 2, 2019

First Submitted That Met QC Criteria

September 2, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Estimated)

September 4, 2025

Last Update Submitted That Met QC Criteria

August 27, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0238

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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