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PSIC-TSA: Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Completed
CT.gov ID
NCT04663022
Collaborator
(none)
33
Enrollment
1
Location
13
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of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

Condition or Disease Intervention/Treatment Phase
  • Other: Dunn's sensory profile questionnaire

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

Study Type:
Observational
Actual Enrollment :
33 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
May 10, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Child with cochlear implant

15 childs with coclear implant but without autism spectrum disorder

Other: Dunn's sensory profile questionnaire
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

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

Outcome Measures

Primary Outcome Measures

  1. determine the sensory profile [inclusion visit]

    To determine the sensory profile of implanted deaf children with autism spectrum disorders, each parent complete the questionnaire Dunn's sensory profile

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Months to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Toulouse Toulouse France 31059

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

  • Principal Investigator: Marie-Noëlle Calmels, MD, University Hospital, Toulouse

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT04663022
Other Study ID Numbers:
  • RC31/20/0328
First Posted:
Dec 10, 2020
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Deafness
Autism Spectrum Disorder

Study Results

No Results Posted as of Aug 19, 2022