Cochlear ImplantationKidTrainNCT06040892
Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children
A study testing SPHERE protocol : Spatial hearing performances test, FRASIMAT Test : audiology test of speech in noise perception and Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale in people with Cochlear Implantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in children, leading to an improvement of their quality of life. However, spatial hearing skills of bCI children remain limited, even for children with the best speech understanding outcomes. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implantation
- What is being tested?
- SPHERE protocol : Spatial hearing performances test, FRASIMAT Test : audiology test of speech in noise perception and Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child aged between 7 and 17 years
- Normal vision (including correction),
- Able to understand the experimental instructions,
- Parents or guardians informed of the study and having signed the consent form,
- Specific for NH:
- Normal tone audiometry (mean threshold ≤ 30 dB). Specific for bIC
- Minimum 2 years of binaural experience,
- Average speech recognition ≥ 80% with both cochlear implants
Who cannot join
- Bilateral vestibular areflexia,
- Attention deficit disorder,
- Known neurological or psychiatric disorders,
- Oculomotor disorders,
- Parents not affiliated to a social security scheme or beneficiaries of a similar scheme who sign the consent for the child's participation,
- Subject participating in other interventional research with an exclusion period still ongoing at inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'Oto-Rhino-Laryngologie et Chirurgie cervico-faciale Hôpital Edouard Herriot, Groupement Hospitalier Centre
Lyon, 69437
Eric TRUY, Pr, 04 72 11 04 92 ext. +33, eric.truy@chu-lyon.fr
Aurélie Coudert, MD, 0427855506 ext. +33, aurelie.coudert2@chu-lyon.fr
About this study
In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in children, leading to an improvement of their quality of life. However, spatial hearing skills of bCI children remain limited, even for children with the best speech understanding outcomes. Recent studies have brought new insights in spatial hearing by using virtual reality to record spatial hearing performance in 3D and the impact of active listening (i.e. free head exploration during sound emission): all bCI children showed spatial hearing difficulties related to front-back confusions and distance perception, which partly resulted from the reduction in auditory cues by the CI settings. However, bCI children notably improved under conditions of active listening, suggesting that interaction with environment could represent a rehabilitation entry strategy to help bCI users when faced with complex auditory scenes in daily life.
The ability to localize sounds in space (spatial hearing) and the ability to understand speech in noise are both auditory skills essential in daily interactions with our physical and social environment and, when deficient, limit the quality of life. However, there is no specific rehabilitation program devoted to spatial hearing which could help children face their daily difficulties in noisy environments. Even though technological advances are crucial to improve the restoration of hearing functions, these improvements are also highly dependent on rehabilitation strategies to train our auditory brain to face the restoration of binaural processing or to decode the impoverished spectral information delivered by the CI.
Read more
The investigators recently performed a pilot study in bCI adults who attended 8 training sessions of spatial hearing, involving a sensorial and interactive immersive environment (i.e. virtual reality with auditory and visual environment during an active listening task). All participants benefitted of the training, in terms of spatial hearing performance, speech understanding in noise, and quality of life. All early benefits were maintained 1 month after the end of training.
The investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults. Their tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location). The KidTrain's effects will be measured with different auditory tests performed in noisy environments. The investigators will also include Normal Hearing (NH) children as age-matched control groups to perform the auditory tests in noise. These NH groups will also bring new insights of spatial hearing maturation in complex auditory environments. Based on our preliminary data in bCI adults, this 'KidTrain program' should improve spatial hearing skills of bCI children, speech comprehension in noise and quality of life in many daily situations.
Virtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains and recent studies have shown that this technology has its place in the auditory evaluation and adaptation of spatial hearing. This VR approach takes advantage of the control of multisensory cues of our environment (audio and visual) during a spatial hearing task, and allows the subject to interact with his environment according to his hearing abilities and needs (i.e. active listening).
Based on their previous study conducted in bCI and NH children and on their spatial training study conducted with bCI adults, the investigators wish to respond to the growing need of spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will improve the spatial training program by adding different immersive environment in VR with various background noise to simulate daily life environments. This approach will also be a great opportunity to characterize the developmental stages of spatial hearing maturation in NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie \& Surdité platform, combining spatial hearing and speech understanding in noise. This innovative and adapted rehabilitation program will lead the speech therapist to propose more adapted and effective rehabilitations for the daily life of deaf children.
- Conditions
- Cochlear Implantation
- Being tested
- SPHERE protocol : Spatial hearing performances test, FRASIMAT Test : audiology test of speech in noise perception, Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale, spatial hearing rehabilitation program
- Keywords
- spatial hearing, virtual reality, hearing loss, rehabilitation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPHERE protocol : Spatial hearing performances testDiagnostic test
Participants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHERE protocol).
FRASIMAT Test : audiology test of speech in noise perceptionDiagnostic test
Intelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening.
Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing ScaleDiagnostic test
The SSQ questionnaire is a clinical subjective scale that allows evaluating of 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.
spatial hearing rehabilitation programOther
The tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | bilateral cochlear implant children with rehabilitation including 8 sessions with a spatialized sensory index Receives: Diagnostic Test: SPHERE protocol : Spatial hearing performances test; Diagnostic Test: FRASIMAT Test : audiology test of speech in noise perception; Diagnostic Test: Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale; Other: spatial hearing rehabilitation program |
| Group B | Experimental | bilateral cochlear implant children with rehabilitation including initially 4 sessions without spatialized sensory cue followed by 4 sessions with spatialized sensory cue Receives: Diagnostic Test: SPHERE protocol : Spatial hearing performances test; Diagnostic Test: FRASIMAT Test : audiology test of speech in noise perception; Diagnostic Test: Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale; Other: spatial hearing rehabilitation program |
| Normal hearing volunteers | Active comparator | Children without known hearing loss Receives: Diagnostic Test: SPHERE protocol : Spatial hearing performances test; Diagnostic Test: FRASIMAT Test : audiology test of speech in noise perception; Diagnostic Test: Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
The effect of spatial rehabilitation will be defined as any change in auditory performance (SPHERE value), between the initial assessment and after 4 training sessions.
Measured: Immediately after 4 training sessions - day 42
To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
The effect of spatial rehabilitation will be defined as any change in auditory performance (FRASIMAT value), between the initial assessment and after 4 training sessions.
Measured: Immediately after 4 training sessions - day 42
To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
The effect of spatial rehabilitation will be defined as any change in auditory performance (KID-SSQ score), between the initial assessment and after 4 training sessions.
Measured: Immediately after 4 training sessions - day 42
Secondary outcomes (10)
To evaluate the compliance of bCI children with the rehabilitation protocol
Number of training sessions attended by bCI patients
Measured: At the end of the study ( Visit 13 - day 98)
To evaluate the impact of a spatialized sensory index in rehabilitation.
Measures obtained at the E2 assessment (SPHERE value) between the group of bCI children in group A and those in group B.
Measured: At the end of the study ( Visit 13 - day 98)
To evaluate the impact of a spatialized sensory index in rehabilitation.
Measures obtained at the E2 assessment (FRASIMAT value) between the group of bCI children in group A and those in group B.
Measured: At the end of the study ( Visit 13 - day 98)
To evaluate the impact of a spatialized sensory index in rehabilitation.
Measures obtained at the E2 assessment (KID-SSQ score) between the group of bCI children in group A and those in group B.
Measured: At the end of the study ( Visit 13 - day 98)
To evaluate the effect in the very short/short and medium term of spatial hearing rehabilitation on the spatial sound localization performance of bIC children compared to NH children
SPHERE confusion rates (front-back, up-down, near-far) for bCI children at E2, E3 and E4 and NH children at E0.
Measured: At evaluation visits Day 0, 42, 77 and 98
To evaluate the effect of very short-term, short-term and medium-term spatial hearing rehabilitation on the speech comprehension performance of bIC children compared to NH children.
FRASIMAT noise intelligibility scores for bCI children in E2, E3 and E4 and those for NH children in E0.
Measured: At evaluation visits Day 0, 42, 77 and 98
To evaluate the effect of very short-term and short-term and medium-term spatial hearing rehabilitation on the quality of life performance of bIC children compared to NH children.
KID-SSQ spatial hearing scores obtained by bCI children in E2, E3 and E4 and those obtained by NH children in E0.
Measured: At evaluation visits Day 0, 42, 77 and 98
To assess the absence of spontaneous changes in auditory performance.
SPHERE measure for the bCI and NH groups between the E0 and E1 assessments.
Measured: At day 0 and 7
To assess the absence of spontaneous changes in auditory performance.
FRASIMAT measure for the bCI and NH groups between the E0 and E1 assessments.
Measured: At day 0 and 7
To assess the absence of spontaneous changes in auditory performance.
KID SSQ measure for the bCI and NH groups between the E0 and E1 assessments.
Measured: At day 0 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start27 Mar 2024
- Primary completion27 Jul 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie Coudert, MD, Study chair, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040892
- Sponsor's protocol ID
- 69HCL22_0893
- Acronym
- KidTrain
- Status last verified
- Feb 2026
- First submitted
- 30 Aug 2023
- Last updated
- 10 Feb 2026
- Results posted
- 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 34225320Valzolgher C, Gatel J, Bouzaid S, Grenouillet S, Todeschini M, Verdelet G, Salemme R, Gaveau V, Truy E, Farne A, Pavani F. Reaching to Sounds Improves Spatial Hearing in Bilateral Cochlear Implant Users. Ear Hear. 2023 Jan-Feb 01;44(1):189-198. doi: 10.1097/AUD.0000000000001267. Epub 2022 Aug 19.
PubMed 35982520Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
PubMed 35943235
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatial Hearing Rehabilitation in Noise for Bilateral Cochlear Implant Children
- ClinicalTrials.gov ID
- NCT06040892
- Acronym / sponsor ID
- KidTrain / 69HCL22_0893
- Conditions
- Cochlear Implantation
- Keywords
- spatial hearing, virtual reality, hearing loss, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 27 Jul 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 18 Sep 2023 (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.
In recent decades, there was a great expansion for bilateral cochlear implantation (bCI) in children, leading to an improvement of their quality of life. However, spatial hearing skills of bCI children remain limited, even for children with the best speech understanding outcomes. Recent studies have brought new insights in spatial hearing by using virtual reality to record spatial hearing performance in 3D and the impact of active listening (i.e. free head exploration during sound emission): all bCI children showed spatial hearing difficulties related to front-back confusions and distance perception, which partly resulted from the reduction in auditory cues by the CI settings. However, bCI children notably improved under conditions of active listening, suggesting that interaction with environment could represent a rehabilitation entry strategy to help bCI users when faced with complex auditory scenes in daily life.
The ability to localize sounds in space (spatial hearing) and the ability to understand speech in noise are both auditory skills essential in daily interactions with our physical and social environment and, when deficient, limit the quality of life. However, there is no specific rehabilitation program devoted to spatial hearing which could help children face their daily difficulties in noisy environments. Even though technological advances are crucial to improve the restoration of hearing functions, these improvements are also highly dependent on rehabilitation strategies to train our auditory brain to face the restoration of binaural processing or to decode the impoverished spectral information delivered by the CI.
The investigators recently performed a pilot study in bCI adults who attended 8 training sessions of spatial hearing, involving a sensorial and interactive immersive environment (i.e. virtual reality with auditory and visual environment during an active listening task). All participants benefitted of the training, in terms of spatial hearing performance, speech understanding in noise, and quality of life. All early benefits were maintained 1 month after the end of training.
The investigators aim to propose a spatial hearing rehabilitation program (KidTrain) adapted to bCI children from 8 to 17 years old, based on their previous pilot study on bCI adults. Their tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location). The KidTrain's effects will be measured with different auditory tests performed in noisy environments. The investigators will also include Normal Hearing (NH) children as age-matched control groups to perform the auditory tests in noise. These NH groups will also bring new insights of spatial hearing maturation in complex auditory environments. Based on our preliminary data in bCI adults, this 'KidTrain program' should improve spatial hearing skills of bCI children, speech comprehension in noise and quality of life in many daily situations.
Virtual reality (VR) has recently proven its effectiveness in rehabilitation in many domains and recent studies have shown that this technology has its place in the auditory evaluation and adaptation of spatial hearing. This VR approach takes advantage of the control of multisensory cues of our environment (audio and visual) during a spatial hearing task, and allows the subject to interact with his environment according to his hearing abilities and needs (i.e. active listening).
Based on their previous study conducted in bCI and NH children and on their spatial training study conducted with bCI adults, the investigators wish to respond to the growing need of spatial hearing rehabilitation for bCI children. To achieve this goal, the investigators will improve the spatial training program by adding different immersive environment in VR with various background noise to simulate daily life environments. This approach will also be a great opportunity to characterize the developmental stages of spatial hearing maturation in NH children. Thus, this project will propose new axes of speech therapy on the Orthophonie \& Surdité platform, combining spatial hearing and speech understanding in noise. This innovative and adapted rehabilitation program will lead the speech therapist to propose more adapted and effective rehabilitations for the daily life of deaf children.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Diagnostic Test: SPHERE protocol : Spatial hearing performances test, Diagnostic Test: FRASIMAT Test : audiology test of speech in noise perception, Diagnostic Test: Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale, Other: spatial hearing rehabilitation programbilateral cochlear implant children with rehabilitation including 8 sessions with a spatialized sensory index |
| Group B | Experimental | Diagnostic Test: SPHERE protocol : Spatial hearing performances test, Diagnostic Test: FRASIMAT Test : audiology test of speech in noise perception, Diagnostic Test: Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale, Other: spatial hearing rehabilitation programbilateral cochlear implant children with rehabilitation including initially 4 sessions without spatialized sensory cue followed by 4 sessions with spatialized sensory cue |
| Normal hearing volunteers | Active comparator | Diagnostic Test: SPHERE protocol : Spatial hearing performances test, Diagnostic Test: FRASIMAT Test : audiology test of speech in noise perception, Diagnostic Test: Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing ScaleChildren without known hearing loss |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child aged between 7 and 17 years
- Normal vision (including correction),
- Able to understand the experimental instructions,
- Parents or guardians informed of the study and having signed the consent form,
- Normal tone audiometry (mean threshold ≤ 30 dB). Specific for bIC
Key exclusion criteria (6 listed)
- Bilateral vestibular areflexia,
- Attention deficit disorder,
- Known neurological or psychiatric disorders,
- Oculomotor disorders,
- Parents not affiliated to a social security scheme or beneficiaries of a similar scheme who sign the consent for the child's participation,
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 |
|---|---|---|
| SPHERE protocol : Spatial hearing performances testParticipants will be instructed to localize a sound emitted in their environment using a virtual reality setup (SPHERE protocol). | Diagnostic test | Group A, Group B, Normal hearing volunteers |
| FRASIMAT Test : audiology test of speech in noise perceptionIntelligibility threshold is the signal-to-noise ratio (in decibels) for which the subject can repeat 50% of the words heard in a dichotic listening. | Diagnostic test | Group A, Group B, Normal hearing volunteers |
| Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing ScaleThe SSQ questionnaire is a clinical subjective scale that allows evaluating of 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. | Diagnostic test | Group A, Group B, Normal hearing volunteers |
| spatial hearing rehabilitation programThe tool makes it possible to propose rehabilitation programs adapted to the performance and expectations of each child. This program will manipulate both the ambient sound with varying background noise to simulate daily life environments (i.e. making auditory detection more or less complex), and also manipulate virtual immersive environment (i.e. giving more or less relevant visual cues related to real sound location). | Other | Group A, Group B |
Primary outcome
To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
Time frame: Immediately after 4 training sessions - day 42
The effect of spatial rehabilitation will be defined as any change in auditory performance (SPHERE value), between the initial assessment and after 4 training sessions.
To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
Time frame: Immediately after 4 training sessions - day 42
The effect of spatial rehabilitation will be defined as any change in auditory performance (FRASIMAT value), between the initial assessment and after 4 training sessions.
To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children.
Time frame: Immediately after 4 training sessions - day 42
The effect of spatial rehabilitation will be defined as any change in auditory performance (KID-SSQ score), between the initial assessment and after 4 training sessions.
10 secondary outcomes
To evaluate the compliance of bCI children with the rehabilitation protocol
Time frame: At the end of the study ( Visit 13 - day 98)
To evaluate the impact of a spatialized sensory index in rehabilitation.
Time frame: At the end of the study ( Visit 13 - day 98)
To evaluate the impact of a spatialized sensory index in rehabilitation.
Time frame: At the end of the study ( Visit 13 - day 98)
To evaluate the impact of a spatialized sensory index in rehabilitation.
Time frame: At the end of the study ( Visit 13 - day 98)
To evaluate the effect in the very short/short and medium term of spatial hearing rehabilitation on the spatial sound localization performance of bIC children compared to NH children
Time frame: At evaluation visits Day 0, 42, 77 and 98
To evaluate the effect of very short-term, short-term and medium-term spatial hearing rehabilitation on the speech comprehension performance of bIC children compared to NH children.
Time frame: At evaluation visits Day 0, 42, 77 and 98
To evaluate the effect of very short-term and short-term and medium-term spatial hearing rehabilitation on the quality of life performance of bIC children compared to NH children.
Time frame: At evaluation visits Day 0, 42, 77 and 98
To assess the absence of spontaneous changes in auditory performance.
Time frame: At day 0 and 7
To assess the absence of spontaneous changes in auditory performance.
Time frame: At day 0 and 7
To assess the absence of spontaneous changes in auditory performance.
Time frame: At day 0 and 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: 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.
- Background: PubMed 35982520Valzolgher C, Gatel J, Bouzaid S, Grenouillet S, Todeschini M, Verdelet G, Salemme R, Gaveau V, Truy E, Farne A, Pavani F. Reaching to Sounds Improves Spatial Hearing in Bilateral Cochlear Implant Users. Ear Hear. 2023 Jan-Feb 01;44(1):189-198. doi: 10.1097/AUD.0000000000001267. Epub 2022 Aug 19.
- Background: PubMed 35943235Coudert A, Verdelet G, Reilly KT, Truy E, Gaveau V. Intensive Training of Spatial Hearing Promotes Auditory Abilities of Bilateral Cochlear Implant Adults: A Pilot Study. Ear Hear. 2023 Jan-Feb 01;44(1):61-76. doi: 10.1097/AUD.0000000000001256. Epub 2022 Aug 9.
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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.
Aurélie Coudert, MD study chair
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPHERE protocol : Spatial hearing performances test, FRASIMAT Test : audiology test of speech in noise perception and Kid SSQ questionnaire of life : The Speech, Spatial and Other Qualities of Hearing Scale in people with Cochlear Implantation, run by Hospices Civils de Lyon at 1 site 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 8 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: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aurélie Coudert, MD (0427855506 ext. +33, aurelie.coudert2@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the very short-term effects of spatial rehabilitation on the auditory performance of bCI children. (time frame: Immediately after 4 training sessions - day 42). The study lists 3 primary outcomes in all. 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 NCT06040892, which also lists 3 linked publications.
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 10 Feb 2026.