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

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Unknown status
CT.gov ID
NCT04183348
Collaborator
(none)
80
Enrollment
2
Locations
2
Arms
18
Anticipated Duration (Months)
40
Patients Per Site
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
Anticipated Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jul 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

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
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.
Experimental: Group B

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
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.

Outcome Measures

Primary Outcome Measures

  1. Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances [1 day]

    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

  1. Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols [1 day]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot Bron France 69675
2 Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Purpan, CHU de Toulouse Toulouse France 31300

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT04183348
Other Study ID Numbers:
  • 69HCL19_0567
First Posted:
Dec 3, 2019
Last Update Posted:
Dec 3, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Cochlear Diseases

Study Results

No Results Posted as of Dec 3, 2019