Evaluating auditory and cognitive functions in deaf children with cochlear implants
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS
NA · University Hospital, Toulouse · NCT04495660
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 10 Months to 7 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse (other) |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT04495660 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with psycho-neurological diseases or other sensorineural or motor deficiencies may not benefit from this study.
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 performed: Other studies have shown promising results in understanding cognitive development in children with cochlear implants, making this approach both relevant and potentially impactful.
Eligibility criteria
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 this trial is running
Toulouse
- Gallois Yohan — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Yohan GALLOIS, MD — University Hospital, Toulouse
- Study coordinator: Yohan GALLOIS, MD
- Email: gallois.y@chu-toulouse.fr
- Phone: 5 61 77 85 97
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Deafness, Functional Neuroimaging, Profound and Severe Hearing Loss, Cochlear implant