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New treatment option for Deafness
Official title Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in FNIRS
ClinicalTrials.gov ID: NCT04495660
What this study is testing
- What it's testing
- 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.
- Time commitment: about 18 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 7
You may be able to join if
- 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 :
You likely can't join if
- Exclusion criteria include psycho-neurological diseases, other sensorineural or motor deficiency, familial bilingualism, medications affecting...
See the full eligibility 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 include psycho-neurological diseases, other sensorineural or motor deficiency, familial bilingualism, medications affecting vigilance and child whose both parents benefit from a legal protection...
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 10 months to 7 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.