Investigating the Neural Oscillatory Features for Limited Access to Oral Language in Deaf Children With Early Bilateral Cochlear Implantation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-17
SponsorInstitut Pasteur

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model

language composite score is the dependent variable

Time frame
at enrollment

Secondary outcomes

1

Power-spectrum density (PSD) of the EEG resting-state oscillations

Time frame
at enrollment
2

peak frequencies of the EEG resting-state oscillations

Time frame
at enrollment
3

Multivariate temporal response functions (mTRF) in audiovisual and audio conditions

Time frame
at enrollment
4

Comparison of the 40Hz Auditory steady-state responses (ASSR) between participants with or without GJB2 variant

Time frame
at enrollment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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