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

Hearing Loss Clinical Trial

— EVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183348
• Other study ID #: 69HCL19_0567
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cochlear Diseases
• Cochlear Hearing Loss
• Cochlear Nerve Deafness
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

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