Spatial Hearing Perception in Bilateral Cochlear Implant Children
SPHERIC1
2 other identifiers
interventional
36
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2018
CompletedFirst Posted
Study publicly available on registry
November 13, 2018
CompletedStudy Start
First participant enrolled
January 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2019
CompletedDecember 19, 2025
December 1, 2025
10 months
October 8, 2018
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
measure of the spatial hearing deficit matching the distance between the hand pointing error and the sound source position in space
Data from spatial sound perception will be recorded in three dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error "D", hence summarizing all three dimensions of space, and taking into account absolute and variable error in one measure.
thirty minutes
Secondary Outcomes (4)
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.
thirty minutes
impact of age at cochlear implantation on spatial hearing deficit
thirty minutes
change of the pupil diameter during a sound localization task
thirty minutes
correlation between a clinical score (SSQ) and sound localization performances
28 days
Study Arms (2)
cochlear implant children
EXPERIMENTAL18 cochlear implant children wil include in this study
normal hearing children
OTHER18 normal hearing children wil include in this study
Interventions
Normal hearing children and cochlear implant children will have to localize a sound source in three dimensional space by using a virtual reality system (Neuro immersion platform). The experiment will last thirty minutes. For normal hearing children, this experience will be performed at the inclusion visit. For cochlear implant children, this experience will be performed 28 days (+/- 2 days) after inclusion.
The SSQ questionnaire for Parents of CI children is composed of three distinct sections (A, B and C). Each section will be filled separately by parents of CI children with one of the study collaborators during 3 telephone calls spaced 1 week apart. Thus, section A will be completed 7 days (+/- 2 days) after inclusion , section B 14 days (+/- 2 days) after inclusion, and section C 21 days (+/- 2 days) after inclusion.
For cochlear implant children and their parents, a SSQ questionnaire will be given and completed during the first visit (at the inclusion). This questionnaire offers a version for parents of children with hearing loss ("SSQ Parents CI") and a version for the children themselves ("SSQ Children CI").
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- neurologic or psychiatric trouble
- visual trouble
- bilateral vestibular areflexia
- 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
- neurologic or psychiatric trouble
- visual trouble
- bilateral vestibular areflexia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Centre de Recherche en Neuroscience de Lyon (CRNL)
Bron, 69676, France
Hôpital Edouard Herriot
Lyon, 69437, France
Related Publications (1)
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.
PMID: 34225320RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric TRUY, PUPH
Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2018
First Posted
November 13, 2018
Study Start
January 24, 2019
Primary Completion
November 18, 2019
Study Completion
November 18, 2019
Last Updated
December 19, 2025
Record last verified: 2025-12