Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT04495660
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Months
Maximum Age:
7 Years
Study:
NCT04495660
Study Brief:
Protocol Section:
NCT04495660