Clinical trial NCT04078763: Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study
Official title: Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Prosthesis Implantation
Keywords: Spatial hearing perception
cochlear prosthesis implantation users
virtual reality
rehabilitation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Short term rehabilitation effect on the spatial auditory performance - 4 sessions
timeFrame: 4 weeks after inclusion
measure: Short term rehabilitation effect on the spatial auditory performance - 8 sessions
timeFrame: 6 weeks after inclusion
Secondary outcomes:
measure: Percentage of sessions performed on all the rehabilitation sessions during the protocol
timeFrame: 6 weeks after inclusion
measure: Middle term rehabilitation effect on the spatial auditory performance
timeFrame: 10 to 12 weeks after inclusion
measure: Measure of auditory performance tests own effect
timeFrame: 2 weeks after inclusion
measure: Short term feedback effect on spatial auditory performance
timeFrame: 4 weeks after inclusion
measure: Short term feedback effect on spatial auditory performance
timeFrame: 6 weeks after inclusion
measure: Middle term feedback effect on spatial auditory performance
timeFrame: 10 to 12 weeks after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Eric TRUY, Professor
role: PRINCIPAL_INVESTIGATOR
References: