Back to resultsEvaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss (EVA)
Primary Purpose
Cochlear Nerve Deafness, Cochlear Diseases, Cochlear Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2
Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2
Sponsored by
About this trial
This is an interventional other trial for Cochlear Nerve Deafness
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
Sites / Locations
- Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot
- Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Purpan, CHU de Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group A
Group B
Arm Description
10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC)
10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04183348
First Posted
November 27, 2019
Last Updated
October 3, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT04183348
Brief Title
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
Acronym
EVA
Official Title
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 6, 2020 (Actual)
Primary Completion Date
May 23, 2022 (Actual)
Study Completion Date
May 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Nerve Deafness, Cochlear Diseases, Cochlear Hearing Loss, Hearing Loss, Deafness
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC)
Arm Title
Group B
Arm Type
Experimental
Arm Description
10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC)
Intervention Type
Behavioral
Intervention Name(s)
Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols
Description
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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot
City
Bron
ZIP/Postal Code
69675
Country
France
Facility Name
Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Purpan, CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31300
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
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