DeafnessPSIC-TSANCT04663022
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation
An observational study of Deafness, run by University Hospital, Toulouse at 1 site in France.
Trial summary
An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it. Read more about this study
- Who is it for?
- Ages 15 months to 10 years
- Conditions the study is for
- Deafness
- What is being tested?
- Dunn's sensory profile questionnaire
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2020to 31 Dec 2021
- Phase
- Observational
- 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 15 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Study population is deaf children with cochlear implant. In the first group, children must have cochlear implant and autism spectrum disorders, and in second group, children must have only cochlear implant.
Who may be able to join
- Deaf child with cochlear implant
- 15 months to 10 years old and 6 months old at the time of implantation
- Child with autism spectrum disorder (only for children group with autisme spectrum disorder)
- No opposition from the legal representative of the authority to participate in the study
Who cannot join
- Opposition by the legal representative of the child
- Child under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it. The aim of this study is to evaluate the causes of this disparity, which is much greater than in children with cochlear implants without associated Autism Spectrum Disorders. Our problem is as follows: do the sensory hypersensitivity and hyposensitivity of deaf children with Autism Spectrum Disorders have an effect on the expected results after a cochlear implantation from a language and auditory reaction point of view?
Read the detailed description
The present study will specifically focus on the sensory profile of these children with Autism Spectrum Disorders, which could be the cause of these developmental difficulties in language and communication development.
- Conditions
- Deafness
- Being tested
- Dunn's sensory profile questionnaire
- Medical subject headings
- Deafness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dunn's sensory profile questionnaireOther
all children will complete the Dunn Sensory Profile questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Child with cochlear implant | 15 childs with coclear implant but without autism spectrum disorder Receives: Other: Dunn's sensory profile questionnaire | |
| Child with cochlear implant and autism spectrum disorder | 15 childs with coclear implant and with autism spectrum disorder Receives: Other: Dunn's sensory profile questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine the sensory profile
To determine the sensory profile of implanted deaf children with autism spectrum disorders, each parent complete the questionnaire Dunn's sensory profile
Measured: inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Dec 2020
- Primary completion10 May 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeafnessStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Noëlle Calmels, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663022
- Sponsor's protocol ID
- RC31/20/0328
- Acronym
- PSIC-TSA
- Status last verified
- Aug 2022
- First submitted
- 3 Dec 2020
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation
- ClinicalTrials.gov ID
- NCT04663022
- Acronym / sponsor ID
- PSIC-TSA / RC31/20/0328
- Conditions
- Deafness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Dec 2020 (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.
An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it. The aim of this study is to evaluate the causes of this disparity, which is much greater than in children with cochlear implants without associated Autism Spectrum Disorders. Our problem is as follows: do the sensory hypersensitivity and hyposensitivity of deaf children with Autism Spectrum Disorders have an effect on the expected results after a cochlear implantation from a language and auditory reaction point of view?
Detailed description
The present study will specifically focus on the sensory profile of these children with Autism Spectrum Disorders, which could be the cause of these developmental difficulties in language and communication development.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Child with cochlear implant | – | Other: Dunn's sensory profile questionnaire15 childs with coclear implant but without autism spectrum disorder |
| Child with cochlear implant and autism spectrum disorder | – | Other: Dunn's sensory profile questionnaire15 childs with coclear implant and with autism spectrum disorder |
Who may qualify
- Ages
- 15 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study population is deaf children with cochlear implant. In the first group, children must have cochlear implant and autism spectrum disorders, and in second group, children must have only cochlear implant.
Key inclusion criteria (4 listed)
- Deaf child with cochlear implant
- 15 months to 10 years old and 6 months old at the time of implantation
- Child with autism spectrum disorder (only for children group with autisme spectrum disorder)
- No opposition from the legal representative of the authority to participate in the study
Key exclusion criteria (2 listed)
- Opposition by the legal representative of the child
- Child under legal protection
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 |
|---|---|---|
| Dunn's sensory profile questionnaireall children will complete the Dunn Sensory Profile questionnaire | Other | Child with cochlear implant, Child with cochlear implant and autism spectrum disorder |
Primary outcome
determine the sensory profile
Time frame: inclusion visit
To determine the sensory profile of implanted deaf children with autism spectrum disorders, each parent complete the questionnaire Dunn's sensory profile
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 Aug 2022.
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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.
Marie-Noëlle Calmels, MD 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?
An observational study of Deafness, 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 2 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 Aug 2022. 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?
determine the sensory profile (time frame: inclusion visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.