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CompletedNCT04183348EVAUpdated Sep 3, 2025

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

An interventional study of Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2 and Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2 in Cochlear Nerve Deafness, Cochlear Diseases and Cochlear Hearing Loss, sponsored by Hospices Civils de Lyon. Completed at 2 sites in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-03.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
79
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cochlear Nerve Deafness
  • Cochlear Diseases
  • Cochlear Hearing Loss
  • Hearing Loss
  • Deafness
03

In context

Hearing Loss, Sensorineural

371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.

This study's enrollment of 79 is above the median of 32 across 264 interventional studies indexed under Hearing Loss, Sensorineural.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • Oculomotor disorder
  • Bilateral vestibular areflexia
  • Neurological and/or psychiatric history
  • Person placed under legal protection, guardianship or trusteeship
  • Pregnant or nursing woman
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
79 participants (actual)

Study arms

  • 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

  • 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

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.

06

What researchers measure

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.

    Time frame: 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

    * 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

07

Study locations

2 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 36905419 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04183348
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Dec 3, 2019
Start date
Jul 6, 2020
Primary completion
May 23, 2022
Completion
May 23, 2022
Last update
Sep 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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