Cochlear Impant ChildrenSPHERIC1NCT03738592
Spatial Hearing Perception in Bilateral Cochlear Implant Children
A study testing behavioral exploration of spatial hearing performances, The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents) and The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children) in people with Cochlear Impant Children, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Impant Children
- What is being tested?
- behavioral exploration of spatial hearing performances, The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents) and The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Jan 2019to 18 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 12Show fewer
- registered with a social security scheme
- 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
Who cannot join
- neurologic or psychiatric trouble
- visual trouble
- bilateral vestibular areflexia
- neurologic or psychiatric trouble
- visual trouble
- bilateral vestibular areflexia
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre de Recherche en Neuroscience de Lyon (CRNL)
Bron, 69676
Hôpital Edouard Herriot
Lyon, 69437
About this study
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.
- Conditions
- Cochlear Impant Children
- Being tested
- behavioral exploration of spatial hearing performances, The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents), The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)
- Keywords
- spatial hearing perception, cochlear implant, child, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral exploration of spatial hearing performancesOther
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 Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents)Other
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").
The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| cochlear implant children | Experimental | 18 cochlear implant children wil include in this study Receives: Other: behavioral exploration of spatial hearing performances; Other: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents); Other: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children) |
| normal hearing children | Other | 18 normal hearing children wil include in this study Receives: Other: behavioral exploration of spatial hearing performances |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: thirty minutes
impact of age at cochlear implantation on spatial hearing deficit
spatial hearing deficit will be correlated to the age at cochlear implantation
Measured: thirty minutes
change of the pupil diameter during a sound localization task
Pupil diameter will be recorded with an eye tracking system during all experiment
Measured: thirty minutes
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".
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start24 Jan 2019
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cochlear Impant ChildrenStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric TRUY, PUPH, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738592
- Sponsor's protocol ID
- 69HCL18_0471
- Other IDs
- 2018-A02509-46
- Acronym
- SPHERIC1
- Status last verified
- Dec 2025
- First submitted
- 8 Oct 2018
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34225320
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Hearing Perception in Bilateral Cochlear Implant Children
- ClinicalTrials.gov ID
- NCT03738592
- Acronym / sponsor ID
- SPHERIC1 / 69HCL18_0471
- Conditions
- Cochlear Impant Children
- Keywords
- spatial hearing perception, cochlear implant, child, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 24 Jan 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cochlear implant children | Experimental | Other: behavioral exploration of spatial hearing performances, Other: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents), Other: The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)18 cochlear implant children wil include in this study |
| normal hearing children | Other | Other: behavioral exploration of spatial hearing performances18 normal hearing children wil include in this study |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- neurologic or psychiatric trouble
- visual trouble
- bilateral vestibular areflexia
- neurologic or psychiatric trouble
- visual trouble
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral exploration of spatial hearing performancesNormal 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. | Other | cochlear implant children, normal hearing children |
| The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents)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"). | Other | cochlear implant children |
| The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)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. | Other | cochlear implant children |
Primary outcome
measure of the spatial hearing deficit matching the distance between the hand pointing error and the sound source position in space
Time frame: thirty minutes
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.
4 secondary outcomes
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.
Time frame: thirty minutes
impact of age at cochlear implantation on spatial hearing deficit
Time frame: thirty minutes
change of the pupil diameter during a sound localization task
Time frame: thirty minutes
correlation between a clinical score (SSQ) and sound localization performances
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 34225320Coudert 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.
Related trials for Cochlear Impant Children
Not yet recruitingObservational study
Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients
Cochlear Impant Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric TRUY, PUPH principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral exploration of spatial hearing performances, The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents) and The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children) in people with Cochlear Impant Children, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of the spatial hearing deficit matching the distance between the hand pointing error and the sound source position in space (time frame: thirty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03738592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.