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Completed

NCT Number: NCT04078763

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

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.

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Key information

Conditions

Cochlear Prosthesis Implantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation protocol with visual-auditory feedback

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: RECOVER

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.