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NCT04663022 Clinical Trial

Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation

Deafness Clinical Trial

— PSIC-TSA  

Official title:
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04663022
Other study ID # RC31/20/0328
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2021

Study information
Verified date August 2022
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them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. 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?

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.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date December 31, 2021
Est. primary completion date May 10, 2021
Accepts healthy volunteers No
Gender All
Age group 15 Months to 10 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Dunn's sensory profile questionnaire
all children will complete the Dunn Sensory Profile questionnaire

Locations
Country Name City State
France University Hospital of Toulouse Toulouse

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 inclusion visit
See also
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Active, not recruiting NCT03352154 - Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants N/A
Recruiting NCT04495660 - Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS N/A