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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10 months
Maximum Age: 7
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
France
Gallois Yohan
RECRUITING
Toulouse
Contact Information
Primary
Yohan GALLOIS, MD
gallois.y@chu-toulouse.fr
5 61 77 85 97
Time Frame
Start Date: 2020-05-29
Estimated Completion Date: 2026-06-03
Participants
Target number of participants: 80
Treatments
Experimental: Severe/profoundly deaf children 10-24 months old
The cohort 1 includes patients aged 10-24 months old about to be implanted
Experimental: Severe/profoundly deaf children 3-7 years old
The cohort 2 includes 3-7 years old cochlear implanted patients (implanted before 24 months of age)
Other: Normally hearing children 10-24 months old
The cohort 1 includes patients aged 10-24 months matched in age and sex with normally hearing children
Other: Normally hearing children 3-7 years old
The cohort 2 includes 3-7 years old matched in sex and age with cochlear implanted patients
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov