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Rehabilitation of the Auditory Space for Bilateral Cochlear Implant Users : a Feasibility Study (RECOVER)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Cochlear Prosthesis Implantation

Treatments

Behavioral: SPHERE protocol
Behavioral: Rehabilitation protocol with visual-auditory feedback
Behavioral: French Matrix Test
Behavioral: Rehabilitation protocol with visual feedback
Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire

Study type

Interventional

Funder types

Other

Identifiers

NCT04078763
69HCL19_0238

Details and patient eligibility

About

A new Neuro-Immersion system based on virtual reality and 3D motion tracking has been developed recently, allowing to evaluate and record the spatial localization performance of cochlear implant (CI) users. This system allows to highlight localization deficits in three-dimensional space for all CI patients. Unfortunately, there is currently no suitable postoperative management for these localization problems. However, the discomfort felt by patients is clearly verbalized. Thanks to the new virtual reality system, it is now possible to develop a rehabilitation protocol adapted to each patient. This project will focus on the evaluation of a spatial auditory rehabilitation, based on unisensory (visual) or multisensory (auditory and visual) feedback, for bilateral CI adults.

Enrollment

12 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18 and 75 years inclusive
  • Use of the second CI for at least 1 year
  • Regular follow-up in the Ear Nose and Throat department of Edouard Herriot Hospital in Lyon
  • Post-lingual deafness
  • Average voice recognition over 80% with 2 Cochlear Implants
  • Normal vision (with or without correction)
  • Able to understand the experimental instructions
  • Affiliated to a social security scheme

Exclusion criteria

  • Oculomotor disorder
  • Bilateral vestibular areflexia

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 2 patient groups

visual-auditory feedback
Experimental group
Description:
Patients included in this arm will follow the rehabilitation protocol with visual-auditory feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
Treatment:
Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire
Behavioral: French Matrix Test
Behavioral: Rehabilitation protocol with visual-auditory feedback
Behavioral: SPHERE protocol
visual feedback
Experimental group
Description:
Patients included in this arm will follow the rehabilitation protocol with visual feedback. Performance of the rehabilitation protocol will be assessed thanks to 3 tests : SPHERE protocol, French Matrix Test and SSQ15 questionnaire
Treatment:
Behavioral: Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire
Behavioral: Rehabilitation protocol with visual feedback
Behavioral: French Matrix Test
Behavioral: SPHERE protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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