About this trial
Children with severe-to-profound congenital hearing loss often experience significant language development challenges. While cochlear implants (CIs) can restore auditory input, outcomes vary widely, even among those who receive implants early (before age 2) and undergo consistent speech therapy. This study aims to identify neural mechanisms underlying these differences.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Between 4 and 17 years old at time of inclusion
Age of first implantation less than or equal to 30 months
Bilateral CIs
Received CIs simultaneously or sequentially (the interval between two implantations does not exceed 18 months)
Disqualifiers
Children with severe associated disabilities who are assessed as unable to complete the tasks
Patients who, in the medical opinion of the Investigator, are unlikely to comply with the study protocol
Trial population
This study will involve minors (between 4 and 17 years-old) with congenital severe-to-profound hearing loss with early bilateral CIs from pediatric ENT department of Necker hospital in Paris.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model
language composite score is the dependent variable
Secondary outcomes
Power-spectrum density (PSD) of the EEG resting-state oscillations
peak frequencies of the EEG resting-state oscillations
Multivariate temporal response functions (mTRF) in audiovisual and audio conditions
Comparison of the 40Hz Auditory steady-state responses (ASSR) between participants with or without GJB2 variant
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: