Clinical trial NCT03738592: Spatial Hearing Perception in Bilateral Cochlear Implant Children
Official title: Spatial Hearing Perception in Bilateral Cochlear Implant Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Impant Children
Keywords: spatial hearing perception
cochlear implant
child
virtual reality
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Spatial hearing in cochlear implant (CI) users is a challenging investigation field since no studies have explored yet spatial auditory perception in three-dimensional space (3D). Moreover auditory rehabilitation after cochlear implantation is totally devoted to speech rehabilitation to date.

A novel methodology based on virtual reality and 3D motion capture protocol in an immersive reality system has recently been developed to evaluate and record spatial hearing abilities of norm-hearing (NH) listeners and CI adults in 3D. The results revealed worse sound localization in 3D for CI users compared to NH participants, and interestingly noted that head movements could improve sound localization performances, leading to a possible track for auditory rehabilitation.

The aim of this study is to explore spatial hearing in CI children with the protocol already tested in CI adults. This protocol will be adapted to children over eight years old. Children will have to perform a sound localization task in 3D without any feedback of performances. The knowledge improvement in pediatric sound localization will lead to develop a specific spatial rehabilitation in cochlear implant children.


Eligibility criteria: Inclusion Criteria for cochlear implant children:

* Age between 8 and 17 included
* second cochlear implant issued within more than 2 years
* mean speech recognition over 80% with two cochlear implants
* normal visual acuity with or without correction
* abilities to understand experimental instructions
* a consent form signed by parents or guardian
* registered with a social security scheme

Exclusion Criteria for cochlear implant children:

* neurologic or psychiatric trouble
* visual trouble
* bilateral vestibular areflexia

Inclusion Criteria for normal hearing children:

* Age between 8 and 17 included
* normal visual acuity with or without correction
* abilities to understand experimental instructions
* a consent form signed by parents or guardian
* registered with a social security scheme

Exclusion Criteria for normal hearing children:

* neurologic or psychiatric trouble
* visual trouble
* bilateral vestibular areflexia

Primary outcomes:
measure: measure of the spatial hearing deficit matching the distance between the hand pointing error and the sound source position in space
timeFrame: thirty minutes
Secondary outcomes:
measure: measure of head and eye movements in three dimensional space with a motion tracking system (virtual reality system including a Head-Mounted display) to evaluate their roles in spatial hearing performances.
timeFrame: thirty minutes
measure: impact of age at cochlear implantation on spatial hearing deficit
timeFrame: thirty minutes
measure: change of the pupil diameter during a sound localization task
timeFrame: thirty minutes
measure: correlation between a clinical score (SSQ) and sound localization performances
timeFrame: 28 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre de Recherche en Neuroscience de Lyon (CRNL)
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Eric TRUY, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coudert A, Gaveau V, Gatel J, Verdelet G, Salemme R, Farne A, Pavani F, Truy E. Spatial Hearing Difficulties in Reaching Space in Bilateral Cochlear Implant Children Improve With Head Movements. Ear Hear. 2022 Jan/Feb;43(1):192-205. doi: 10.1097/AUD.0000000000001090.