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 type | Interventional |
|---|---|
| Ages | 10 Months to 7 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Status | Recruiting |
| Started | May 29, 2020 |
| Main results expected | June 3, 2027 |
| Study ends | June 3, 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT04495660 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
- 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Customizing cochlear implant programming based on inner ear nerve health
This study tests whether tailoring cochlear implant programming to how healthy different parts of the hearing nerve are can improve understanding of speech in noisy environments.
-
Long-term hearing and speech outcomes after cochlear implants
This project will see if cochlear implants improve hearing, speech understanding, and quality of life in Mandarin-speaking patients of all ages before and after surgery.
-
Reducing follow-up visits for cochlear implant patients using a new mapping strategy
This study is testing a new way to program cochlear implants to see if adults can have fewer follow-up visits while still feeling satisfied and hearing well.
-
Cisplatin-related (Ear) Hearing Loss and Balance Issues in Head and Neck Cancer Patients
This observational study tests whether hearing loss, tinnitus, and balance problems occur in head and neck cancer patients treated with cisplatin chemoradiotherapy compared with those receiving only radiotherapy, including optional genetic tests for susceptibility.
-
Early hearing loss detection in a memory clinic
This project uses a VRB speech-in-noise test to try to detect hearing problems in people with mild to moderate cognitive impairment seen at a memory clinic.
-
Understanding how cochlear implants affect hearing in children and adults
This study is trying to see how cochlear implants help both children and adults hear better and how they adjust to the changes over time.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.