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

August 26, 2025 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69675
        • Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot
      • Toulouse, France, 31300
        • Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Purpan, CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite measure of spatial localization auditory tasks effect of each training protocol on spatial auditory performances
Time Frame: 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.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of the sensory feedback effect on spatial auditory performance by comparing the composite measure of the two training protocols
Time Frame: 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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2020

Primary Completion (Actual)

May 23, 2022

Study Completion (Actual)

May 23, 2022

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

December 2, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Estimated)

September 3, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL19_0567

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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