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

Civil Hospices of Lyon

Status: Completed

Conditions: Cochlear Nerve Deafness; Hearing Loss; Cochlear Diseases; Deafness; Cochlear Hearing Loss

Treatments: Behavioral: Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2; Behavioral: Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04183348

69HCL19_0567

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

79 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

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

Group B

Experimental group

Description:

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

Treatment:

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