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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date May 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2
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.
Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2
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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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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