Evaluation of the Effect of a Visio-Hearing Training Protocol on Spatial Hearing in Subjects With Hearing Loss
EVA
1 other identifier
interventional
79
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2020
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedStudy Start
First participant enrolled
July 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2022
CompletedSeptember 3, 2025
August 1, 2025
1.9 years
November 27, 2019
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols
1 day
Study Arms (2)
Group A
EXPERIMENTAL10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC)
Group B
EXPERIMENTAL10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Oculomotor disorder
- Bilateral vestibular areflexia
- Neurological and/or psychiatric history
- Person placed under legal protection, guardianship or trusteeship
- Pregnant or nursing woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot
Bron, 69675, France
Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Purpan, CHU de Toulouse
Toulouse, 31300, France
Related Publications (1)
Valzolgher C, Bouzaid S, Grenouillet S, Gatel J, Ratenet L, Murenu F, Verdelet G, Salemme R, Gaveau V, Coudert A, Hermann R, Truy E, Farne A, Pavani F. Training spatial hearing in unilateral cochlear implant users through reaching to sounds in virtual reality. Eur Arch Otorhinolaryngol. 2023 Aug;280(8):3661-3672. doi: 10.1007/s00405-023-07886-1. Epub 2023 Mar 11.
PMID: 36905419BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2019
First Posted
December 3, 2019
Study Start
July 6, 2020
Primary Completion
May 23, 2022
Study Completion
May 23, 2022
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share