Clinical trial Recruiting at 1 site Interventional Ages 10 Months to 7

Evaluating auditory and cognitive functions in deaf children with cochlear implants

Official title: Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS

Run by University Hospital, Toulouse · NCT04495660 · Data updated 2026-11-12

This study tests how cochlear implants help young deaf children develop their hearing and thinking skills compared to children who can hear normally.

Quick facts

Study typeInterventional
Ages10 Months to 7 Years
SexAll
Enrollment80 (estimated)
SponsorUniversity Hospital, Toulouse
Academic / other
Locations1 site (Toulouse)
StatusRecruiting
StartedMay 29, 2020
Main results expectedJune 3, 2027
Study endsJune 3, 2027
Registry record updatedAugust 31, 2026
Trial IDNCT04495660 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include congenitally deaf children aged 10-24 months or 3-7 years who are about to receive a cochlear implant or have already been implanted before the age of 2.

Probably not a fit

Patients with psycho-neurological diseases or other sensorineural or motor deficiencies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the development of perceptual skills and executive functions in children with cochlear implants aged 10-24 months and 3-7 years, comparing them to normally hearing peers. Using functional Near Infrared Spectroscopy (fNIRS), the researchers will analyze cortical activity during various cognitive and perceptual tasks over an 18-month period. Participants will undergo five sessions, including speech and language assessments, to track their progress and development. The study focuses on understanding how early cochlear implantation impacts cognitive and auditory function.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how cochlear implants affect cognitive and auditory development in young children, leading to improved interventions.

How similar studies have gone: Other studies have shown promising results in understanding cognitive development in children with cochlear implants, making this approach both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Gallois Yohan
    Toulouse, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.