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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04183348
Acronym
EVA
Enrollment
79
Registered
2019-12-03
Start date
2020-07-06
Completion date
2022-05-23
Last updated
2025-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cochlear Diseases, Cochlear Hearing Loss, Cochlear Nerve Deafness, Deafness, Hearing Loss

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.

Interventions

BEHAVIORALTraining 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.

BEHAVIORALTraining 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances1 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

MeasureTime frameDescription
Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols1 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026