Cochlear ImplantationH2R2NCT04832373
Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2
A study testing Interaction with humanoid robot in people with Cochlear Implantation, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The quality of the rehabilitation of deafness in children with cochlear implantation is a major prognostic factor for the outcome on speech comprehension and oral expression. This rehabilitation is carried out cooperatively by the hospital cochlear implantation team, and by a speech therapist located near the child's… Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cochlear Implantation
- What is being tested?
- Interaction with humanoid robot
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2021to 29 Mar 2023
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child aged 8 to 12, user of his cochlear implant with a favorable family environment,
- Child implanted with at least one cochlear implant undergoing speech therapy rehabilitation, and monitored by the pediatric cochlear implant unit (UPIC) of the Toulouse University Hospital
- Child and his family whose mother tongue is French
- Affiliation to a social security scheme
Who cannot join
- Cognitive or psychological inability or refusal of the participant to give written consent
- Other sensory or motor deficit that may interfere with the use of the robot
- Unstable psychiatric pathology
- Child with both parents benefiting from a legal protection measure
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse - Service d'ORL, ORL pédiatrique et Otoneurologie
Toulouse, 31059
About this study
The quality of the rehabilitation of deafness in children with cochlear implantation is a major prognostic factor for the outcome on speech comprehension and oral expression. This rehabilitation is carried out cooperatively by the hospital cochlear implantation team, and by a speech therapist located near the child's home. The multi-weekly sessions represent a constraint for the child and his parents. Complementary training work at home would make it possible to balance the equity in the distribution of care in the territory, and should promote the progress of the child, who is more inclined to use a tool available at home.
Read the detailed description
The humanoid robot should allow an ecological approach to this additional rehabilitation. Before developing this approach, it is necessary to study the acceptability of the humanoid robot at home, both by the parents and by the cochlear implanted child. The main objective of this study is to assess the acceptability by the child and his family, of a humanoid robot installed at home for one month.
The secondary objectives are to describe the acceptability of the child and his family that is the relationship to technology, the intention of use, expectations, perceived utility, perception of the robot and facilitating conditions before then after 1 month of using the robot at home,
- describe the child's acceptability with respect to his experience, his fun and the emotions felt when he uses the robot at home
- Conditions
- Cochlear Implantation
- Being tested
- Interaction with humanoid robot
- Keywords
- cochlear implantation, humanoid robot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction with humanoid robotDevice
A humanoid robot will be installed for 30 days in children. It has a touchscreen tablet, allowing manual interaction complementing the voice interaction. The robot speaks, hears, and has facial and voice identification.
| Study group | Role | What they receive |
|---|---|---|
| Humanoid Robot | Other | Not described Receives: Device: Interaction with humanoid robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of a humanoid robot
assess by the number of weekly hours during which the child uses the robot.
Measured: month 1
Secondary outcomes (8)
Relationship to technology
Assessment by a set of questionnaires and standardized scales validated by the scientific community
Measured: month 1
Intention of use
Assessment by a set of questionnaires and standardized scales validated by the scientific community
Measured: month 1
Relationship with the robot
Assessment by a set of questionnaires and standardized scales validated by the scientific community
Measured: month 1
User experience
Assessment by a set of questionnaires and standardized scales validated by the scientific community
Measured: Month 1
participants' expectations
Measurement by sentence completion which consists of giving the beginning of a sentence and letting the user complete the rest of the sentence
Measured: Month 1
3Emethod
Evaluation of emotions in the form of a drawing with a speech bubble and a thought bubble.
Measured: Month 1
classification of activities
classification according to various criteria (good functioning, fun, ease of use)
Measured: Month 1
Feedback
with a Semi-structured interview on the use of the robot
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start17 Sep 2021
- Primary completion29 Mar 2023
- Study completion29 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University Hospital, ToulouseThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Olivier DEGUINE, PH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832373
- Sponsor's protocol ID
- RC31/20/0250
- Other IDs
- 2020-A01989-30.
- Acronym
- H2R2
- Status last verified
- Feb 2024
- First submitted
- 31 Mar 2021
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stiti S, Caroux L, Gaillard P, Paubel PV, Deguine O. Innovative protocol of an exploratory study evaluating the acceptability of a humanoid robot at home of deaf children with cochlear implants. PLoS One. 2023 Jun 16;18(6):e0285927. doi: 10.1371/journal.pone.0285927. eCollection 2023.
PubMed 37327230Diehl JJ, Schmitt LM, Villano M, Crowell CR. The Clinical Use of Robots for Individuals with Autism Spectrum Disorders: A Critical Review. Res Autism Spectr Disord. 2012 Jan;6(1):249-262. doi: 10.1016/j.rasd.2011.05.006.
PubMed 22125579
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Acceptability of a Humanoid Robot at Home for Children With Cochlear Implants - H2R2
- ClinicalTrials.gov ID
- NCT04832373
- Acronym / sponsor ID
- H2R2 / RC31/20/0250
- Conditions
- Cochlear Implantation
- Keywords
- cochlear implantation, humanoid robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 29 Mar 2023 (actual)
- Study completion
- 29 Mar 2023 (actual)
- First posted
- 5 Apr 2021 (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.
The quality of the rehabilitation of deafness in children with cochlear implantation is a major prognostic factor for the outcome on speech comprehension and oral expression. This rehabilitation is carried out cooperatively by the hospital cochlear implantation team, and by a speech therapist located near the child's home. The multi-weekly sessions represent a constraint for the child and his parents. Complementary training work at home would make it possible to balance the equity in the distribution of care in the territory, and should promote the progress of the child, who is more inclined to use a tool available at home.
Detailed description
The humanoid robot should allow an ecological approach to this additional rehabilitation. Before developing this approach, it is necessary to study the acceptability of the humanoid robot at home, both by the parents and by the cochlear implanted child. The main objective of this study is to assess the acceptability by the child and his family, of a humanoid robot installed at home for one month.
The secondary objectives are to describe the acceptability of the child and his family that is the relationship to technology, the intention of use, expectations, perceived utility, perception of the robot and facilitating conditions before then after 1 month of using the robot at home,
- describe the child's acceptability with respect to his experience, his fun and the emotions felt when he uses the robot at home
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Humanoid Robot | Other | Device: Interaction with humanoid robot |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child aged 8 to 12, user of his cochlear implant with a favorable family environment,
- Child implanted with at least one cochlear implant undergoing speech therapy rehabilitation, and monitored by the pediatric cochlear implant unit (UPIC) of the Toulouse University Hospital
- Child and his family whose mother tongue is French
- Affiliation to a social security scheme
Key exclusion criteria (4 listed)
- Cognitive or psychological inability or refusal of the participant to give written consent
- Other sensory or motor deficit that may interfere with the use of the robot
- Unstable psychiatric pathology
- Child with both parents benefiting from a legal protection measure
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 |
|---|---|---|
| Interaction with humanoid robotA humanoid robot will be installed for 30 days in children. It has a touchscreen tablet, allowing manual interaction complementing the voice interaction. The robot speaks, hears, and has facial and voice identification. | Device | Humanoid Robot |
Primary outcome
Acceptability of a humanoid robot
Time frame: month 1
assess by the number of weekly hours during which the child uses the robot.
8 secondary outcomes
Relationship to technology
Time frame: month 1
Intention of use
Time frame: month 1
Relationship with the robot
Time frame: month 1
User experience
Time frame: Month 1
participants' expectations
Time frame: Month 1
3Emethod
Time frame: Month 1
classification of activities
Time frame: Month 1
Feedback
Time frame: Month 1
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 5 Dec 2025.
- Background: PubMed 37327230Stiti S, Caroux L, Gaillard P, Paubel PV, Deguine O. Innovative protocol of an exploratory study evaluating the acceptability of a humanoid robot at home of deaf children with cochlear implants. PLoS One. 2023 Jun 16;18(6):e0285927. doi: 10.1371/journal.pone.0285927. eCollection 2023.
- Background: PubMed 22125579Diehl JJ, Schmitt LM, Villano M, Crowell CR. The Clinical Use of Robots for Individuals with Autism Spectrum Disorders: A Critical Review. Res Autism Spectr Disord. 2012 Jan;6(1):249-262. doi: 10.1016/j.rasd.2011.05.006.
- Individual participant dataSharing planned: No
Related trials for Cochlear Implantation
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Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
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Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
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Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
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Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
Deafness
Not yet recruitingObservational study
Mi2000 TICI Follow-up
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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. This study is not recruiting at the moment.
Olivier DEGUINE, PH principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction with humanoid robot in people with Cochlear Implantation, run by University Hospital, Toulouse 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 4 inclusion and 4 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 5 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 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?
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?
Acceptability of a humanoid robot (time frame: month 1). 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 NCT04832373, which also lists 2 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 5 Dec 2025.