Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss

Study Overview
=================
Brief Summary
-----------------
We recently developed a new Neuro-immersion system based on virtual reality and 3D (dimension) motion tracking. This tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. Unfortunately, there is currently no suitable support to compensate for these localization deficits. However, the discomfort felt by the patients is clearly verbalized. Thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.

Official Title
-----------------
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss

Conditions
-----------------
Cochlear Nerve Deafness, Cochlear Diseases, Cochlear Hearing Loss, Hearing Loss, Deafness

Intervention / Treatment
-----------------
* Behavioral: Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2
* Behavioral: Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For all participants (patients and normal hearing adults): Ages 18 and 65 Normal vision (with or without correction) Able to understand experimental instructions Member of the social security scheme Informed of the study and signed the consent form For hearing standards (NH): - No hearing problems For patients (SU, uIC and bIC): Regular follow-up in the ENT (Ear, nose, and throat) department of the Edouard Herriot Hospital in Lyon or the Purpan Hospital, in Toulouse Unilateral deep deafness (only for SU patients) Holder of one Cochlear implant for more than one year (only for uIC patients) Holder of the second Cochlear implant for more than one year (only for bIC patients) Exclusion Criteria: Oculomotor disorder Bilateral vestibular areflexia Neurological and/or psychiatric history Person placed under legal protection, guardianship or trusteeship Pregnant or nursing woman

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC) | Behavioral: Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2<br>* During Protocol 1 (visit 1), participants of Group A will perform auditory spatial localization tasks with sensory feedback and during Protocol 2 (visit 2), they will perform auditory tasks without any notion of spatial localization. The 2 visits will be spaced at least 2 weeks (Wash-out). The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol.<br>|
| Experimental: Group B<br>10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC) | Behavioral: Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2<br>* During Protocol 2 (visit 1), participants of Group B will perform auditory tasks without any notion of spatial localization and during Protocol 1 (visit 2), they will perform auditory spatial localization tasks with sensory feedback. The 2 visits will be spaced at least 2 weeks (Wash-out). The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances | Explicit spatial auditory performances (2d-D) is the combined (head) pointing error, corresponding to the distance in the space between the exact position of the target and the pointing of the subject. In other words, the more precise the subject becomes in his location of a sound source and the lower the value of 2d-D. Implicit spatial auditory performances (called RT) is the response time between the participant's response and the light point. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols | Explicit spatial auditory performances (2d-D) is the combined (head) pointing error, corresponding to the distance in the space between the exact position of the target and the pointing of the subject. In other words, the more precise the subject becomes in his location of a sound source and the lower the value of 2d-D. Implicit spatial auditory performances (called RT) is the response time between the participant's response and the light point | 1 day |