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

NCT04663022 | Completed

• 1 other identifier: RC31/20/0328
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of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

Conditions

Deafness

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Child with cochlear implant

15 childs with coclear implant but without autism spectrum disorder

Other: Dunn's 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

Interventions

Dunn's sensory profile questionnaire OTHER

all children will complete the Dunn Sensory Profile questionnaire

Child with cochlear implant; Child with cochlear implant and autism spectrum disorder

Eligibility Criteria

• Age: 15 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Deaf child with cochlear implant
• 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

You may not qualify if:

• Opposition by the legal representative of the child
• Child under legal protection

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Deafness

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie-Noëlle Calmels, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: December 1, 2020
• Primary Completion: May 10, 2021
• Study Completion: December 31, 2021
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

FR (1)