Hearing Loss Clinical Trial
— EVAOfficial title:
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
NCT number | NCT04183348 |
Other study ID # | 69HCL19_0567 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 6, 2020 |
Est. completion date | May 23, 2022 |
Verified date | May 2023 |
Source | Hospices Civils de Lyon |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | May 23, 2022 |
Est. primary completion date | May 23, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot | Bron | |
France | Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Purpan, CHU de Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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