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

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ClinicalTrials.gov Identifier: NCT04663022
Recruitment Status : Recruiting
First Posted : December 10, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them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
Deafness 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
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Study Type : Observational
Estimated Enrollment : 30 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 : December 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   15 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663022


Contacts
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Contact: Marie-Noëlle Calmels, MD 05 61 77 90 09 ext 33 calmels.mn@chu-toulouse.fr
Contact: Nadine Cochard 05 61 77 25 37 ext 33 cochard@chu-toulouse.fr

Locations
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France
University Hospital of Toulouse Recruiting
Toulouse, France, 31059
Contact: Marie-Noëlle Calmels, MD    05 61 77 90 09 ext 33    calmels.mn@chu-toulouse.fr   
Contact: Nadine Cochard    05 61 77 25 37 ext 33    cochard@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Marie-Noëlle Calmels, MD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04663022    
Other Study ID Numbers: RC31/20/0328
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deafness
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Hearing Loss
 Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases