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Search / Trial NCT04495660

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

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Jul 28, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Functional Neuroimaging Profound And Severe Hearing Loss Cochlear Implant

ClinConnect Summary

This clinical trial is studying how cochlear implants, which help children with severe to profound hearing loss, affect their ability to perceive sounds and think over time. The researchers want to understand how the brain develops these skills in young children with cochlear implants, compared to children who can hear normally. They will use a special tool called functional Near Infrared Spectroscopy (fNIRS) to measure brain activity while children complete tasks that challenge their thinking and listening abilities over 18 months.

To participate in this study, children must be between 10 months to 7 years old and have parental consent. There are two groups: one for children aged 10-24 months who are about to receive a cochlear implant, and another for children aged 3-7 years who already have one. Participants need to have a specific type of hearing loss or be normally hearing, confirmed by a simple hearing test. Throughout the study, children will engage in activities while their brain responses are recorded, helping researchers learn more about how cochlear implants can improve hearing and cognitive functions in young children.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * 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 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

About University Hospital, Toulouse

The University Hospital of Toulouse is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital integrates cutting-edge scientific inquiry with comprehensive clinical services. Its multidisciplinary team of healthcare professionals collaborates with renowned researchers to facilitate pioneering studies across various medical fields, aiming to enhance treatment options and improve patient outcomes. As a prominent institution in the region, the University Hospital of Toulouse is committed to fostering an environment of excellence in both education and research within the healthcare community.

Locations

Toulouse, , France

Patients applied

0 patients applied

Trial Officials

Yohan GALLOIS, MD

Principal Investigator

University Hospital, Toulouse

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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