- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663022
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation (PSIC-TSA)
August 18, 2022 updated by: University Hospital, Toulouse
An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
33
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France, 31059
- University Hospital of Toulouse
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 weeks to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Opposition by the legal representative of the child
- Child under legal protection
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Child with cochlear implant
15 childs with coclear implant but without autism spectrum disorder
|
all children will complete the Dunn Sensory Profile questionnaire
|
Child with cochlear implant and autism spectrum disorder
15 childs with coclear implant and with autism spectrum disorder
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all children will complete the Dunn Sensory Profile questionnaire
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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inclusion visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-Noëlle Calmels, MD, University Hospital, Toulouse
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2020
Primary Completion (Actual)
May 10, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
December 3, 2020
First Submitted That Met QC Criteria
December 3, 2020
First Posted (Actual)
December 10, 2020
Study Record Updates
Last Update Posted (Actual)
August 19, 2022
Last Update Submitted That Met QC Criteria
August 18, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC31/20/0328
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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