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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT06051006
Eligibility Criteria:
Inclusion Criteria:
* Patients between the ages of 8-17 years at the time of inclusion with cochlear implants for at least 1 year and followed at Hôpital Necker-Enfants malades
* Use oral French as the main mode of communication
* Have a tonal threshold with the cochlear implant of 40 dB or more
* Have a normal tympanogram
* Have a voice threshold of less than 70% at 30dB HL
* Information and non-opposition of holders of parental authority and minor patients to participate in the study
Exclusion Criteria:
* Present a severe neurological pathology before inclusion (which can be identified by an MRI +/- a neuro-pediatric assessment)
* Present, on inclusion, a cognitive or psychiatric impairment or severe developmental delay
* Be part of a family that does not understand oral French
* Patients under AME (State Medical Aid)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT06051006
Study Brief:
Protocol Section:
NCT06051006