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

NCT04078763 | Completed

• 1 other identifier: 69HCL19_0238
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cochlear Prosthesis Implantation

Keywords

Spatial hearing perception; cochlear prosthesis implantation users; virtual reality; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• 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

  10 to 12 weeks after inclusion

• Measure of auditory performance tests own effect

  2 weeks after inclusion

• Short term feedback effect on spatial auditory performance

  4 weeks after inclusion

• Short term feedback effect on spatial auditory performance

  6 weeks after inclusion

Study Arms (2)

visual-auditory feedback

EXPERIMENTAL

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; Behavioral: SPHERE protocol; Behavioral: French Matrix Test; Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire

visual feedback

EXPERIMENTAL

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: Rehabilitation protocol with visual feedback; Behavioral: SPHERE protocol; Behavioral: French Matrix Test; Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire

Interventions

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

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.

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

visual feedback; visual-auditory feedback

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.

visual feedback; visual-auditory feedback

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.

visual feedback; visual-auditory feedback

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Oculomotor disorder
• Bilateral vestibular areflexia

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Edouard Herriot

Lyon, 69003, France

Location

Related Publications (1)

• Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.

  PMID: 35943235 RESULT

MeSH Terms

Interventions

Feedback, Sensory; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric TRUY, Professor

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 6, 2019
• Study Start: October 25, 2019
• Primary Completion: September 4, 2020
• Study Completion: September 4, 2020
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

FR (1)