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OpenTrials
Completed

NCT Number: NCT04183348

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale, Hôpital Edouard Herriot, Bron, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: EVA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2019
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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