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Clinical Trials/NCT04495660
NCT04495660
Recruiting
N/A

Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS

University Hospital, Toulouse1 site in 1 country80 target enrollmentMay 29, 2020
ConditionsDeafness

Overview

Phase
N/A
Intervention
Not specified
Conditions
Deafness
Sponsor
University Hospital, Toulouse
Enrollment
80
Locations
1
Primary Endpoint
Evolution of Oxyhemoglobin (O2Hb) measure
Status
Recruiting
Last Updated
last year

Overview

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 compared with normally hearing subjects (NHS). To do this, the investigator will use functional Near InfraRed Spectroscopy (fNIRS) during 4 tasks that engage the childs perceptual and cognitive skills over a period of 18 months. The performance scores obtained by each participants as well as the cortical activity will be analysed and decrypted.

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 language acquisition for communication purposes. When cochlear implantation is done before 2 and a half years old, better results are obtained in terms of language, communication and social developement, as well as reading skills. However when a cochlear implantation occurs between 2 and 5 years of age, speech and language skills do develop but communication and reading skills are altered. Therefore, when a cochlear implant is placed before the age of 2 and a half we find ourselves within the maximal cerebral plasticity window for speech, language and communication developement. This study is divided into two cohorts, the first aged 10-24 months and the second 3-7 years. All children will be seen for 5 sessions, spread out at regular intervals, over a period of 18 months and will participate in two perceptual tasks and two cognitive tasks. The children will also have a speech and language assessment at T-0 and T+12. The cochlear implanted patients will continue to be seen by the ENT service and the sessions will be organised to coincide with their natural follow up. As it is a non-interventional study, no follow-up would be needed. After the study patients will continue to receive the same quality of care.

Registry
clinicaltrials.gov
Start Date
May 29, 2020
End Date
June 3, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria:
  • 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.
  • 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 Criteria

  • 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

Outcomes

Primary Outcomes

Evolution of Oxyhemoglobin (O2Hb) measure

Time Frame: 60 months

Oxyhemoglobin (O2Hb) rates measured on the auditory cortex during an auditory stimulus.

Evolution of Deoxyhemoglobin (HHb) measure

Time Frame: 60 months

Deoxyhemoglobin (HHb) rates measured on the auditory cortex during an auditory stimulus.

Secondary Outcomes

  • Activation of the cortical area for children with normal hearing and children benefiting from CI(60 months)
  • Look the executive function when performing tasks describe in Arms and intervention chapter, between children with normal hearing and children benefiting from CI(60 months)
  • Comparison(60 months)
  • Correlation of link between the evolution of perceptual hearing skills and the development of post-implantation language skills.(60 months)
  • Make activation cards of the cortical reorganization between these two groups(60 months)

Study Sites (1)

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