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An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of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

  • France
      • Toulouse, France, 31059
        • University Hospital of Toulouse

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

2 years to 6 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
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

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
inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

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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