RecruitingNot Applicable

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

France80 participantsStarted 2020-05-29

Plain-language 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.

Who can participate

Age range

10 Months – 7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Evolution of Oxyhemoglobin (O2Hb) measure

Timeframe: 60 months

Evolution of Deoxyhemoglobin (HHb) measure

Timeframe: 60 months

Trial details

NCT IDNCT04495660

SponsorUniversity Hospital, Toulouse

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-03

Contact for this trial

Yohan GALLOIS, MD

5 61 77 85 97 gallois.y@chu-toulouse.fr

View on ClinicalTrials.gov More Deafness trials