Investigating the Neural Oscillatory Features for Limited Access to Oral Language in Deaf Children With Early Bilateral Cochlear Implantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Congenital Hearing Loss, Bilateral Cochlear Implants. Basic parameters: 4 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect model [Time frame: at enrollment]
Secondary outcome measures (4)
- Power-spectrum density (PSD) of the EEG resting-state oscillations [Time frame: at enrollment]
- peak frequencies of the EEG resting-state oscillations [Time frame: at enrollment]
- Multivariate temporal response functions (mTRF) in audiovisual and audio conditions [Time frame: at enrollment]
- Comparison of the 40Hz Auditory steady-state responses (ASSR) between participants with or without GJB2 variant [Time frame: at enrollment]
Eligibility criteria
Inclusion criteria
- 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)
- Congenital severe-to-profound hearing loss (PTA ≥90 dB HL)
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07739433 · 2025-067