Cochlear Impant Children Clinical Trial
— SPHERIC1Official title:
Spatial Hearing Perception in Bilateral Cochlear Implant Children
| Verified date | November 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | November 18, 2019 |
| Est. primary completion date | November 18, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 8 Years to 17 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre de Recherche en Neuroscience de Lyon (CRNL) | Bron | |
| France | Hôpital Edouard Herriot | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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. | Head and eye movements will be recorded in three dimensional space with a motion tracking system (virtual reality system including a Head-Mounted display). The cumulative error "D" will be calculated in two different conditions: first, participant's head will be fixed during sound emission and then, head and eyes will be free to move. If the cumulative error "D" significantly decreases when head movements are free, we could say that head movements allow/help improving spatial hearing performances. | thirty minutes | |
| Secondary | impact of age at cochlear implantation on spatial hearing deficit | spatial hearing deficit will be correlated to the age at cochlear implantation | thirty minutes | |
| Secondary | change of the pupil diameter during a sound localization task | Pupil diameter will be recorded with an eye tracking system during all experiment | thirty minutes | |
| Secondary | correlation between a clinical score (SSQ) and sound localization performances | The SSQ questionnaire is a clinical subjective scale adapted to parents and cochlear implant children. It allows evaluating hearing performances in daily life. The questionnaire is divided into 3 main items (A: speech; B: spatial hearing; C: other qualities of hearing) comprising questions with rating scores out of ten. For example, a zero score corresponds to bad hearing abilities. We will therefore correlate the mean score of all questions out of ten to the cumulative error "D". | 28 days |