Status:
RECRUITING
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Deafness
Eligibility:
All Genders
10-7 years
Phase:
NA
Brief Summary
The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years comp...
Detailed Description
When confronted with a severe to profound congenital bilateral hearing loss, cochlear implantation is considered to be the preferential treatment method as it restaures auditory function and enables l...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Cohort 1 :
- 10-24 months old children will be included.
- All participants have to be affiliated to the social health security system and parental consent is obligatory.
- All congenitally deaf patients will have a severe to profound hearing loss and about to be fitted with a cochlear implant.
- Normally hearing counterparts shall have normal hearing as evidenced by acoustical otoemissions (AOE) in both ears.
- Cohort 2 :
- 3-7 years old children will be included.
- All participants have to be affiliated to the social health security system and parental consent is obligatory.
- All congenitally deaf patients will have a cochlear implant, and they will have been implanted before 2 years of age.
- Normally hearing counterparts shall have normal hearing as evidenced by acoustical otoemissions (AOE) in both ears.
Exclusion
- Exclusion criteria include psycho-neurological diseases, other sensorineural or motor deficiency, familial bilingualism, medications affecting vigilance and child whose both parents benefit from a legal protection measure
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 3 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04495660
Start Date
May 29 2020
End Date
June 3 2026
Last Update
October 23 2024
Active Locations (1)
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1
Gallois Yohan
Toulouse, France