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

NCT ID: NCT04183348

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-06
• Study Completion Date: 2022-05-23

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.

Conditions

Cochlear Nerve Deafness; Cochlear Diseases; Cochlear Hearing Loss; Hearing Loss; Deafness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A

10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC)

Group Type: EXPERIMENTAL

Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2

Intervention Type: BEHAVIORAL

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.

Group B

10 normal hearing adults (NH) 10 unilateral deafness adults (SU) 10 mono-implanted adults (uIC) 10 bi-implanted adults (bIC)

Group Type: EXPERIMENTAL

Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 36905419 (View on PubMed)

Other Identifiers

69HCL19_0567

Identifier Type: -

Identifier Source: org_study_id