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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07739433
Acronym
ICO
Enrollment
150
Registered
2026-07-31
Start date
2026-09-01
Completion date
2028-09-01
Last updated
2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Cochlear Implants, Congenital Hearing Loss

Brief summary

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.

Interventions

None listed

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The beta coefficient of theta-gamma phase-amplitude coupling (PAC) in the linear mixed-effect modelat enrollmentlanguage composite score is the dependent variable

Secondary

MeasureTime frame
Power-spectrum density (PSD) of the EEG resting-state oscillationsat enrollment
peak frequencies of the EEG resting-state oscillationsat enrollment
Multivariate temporal response functions (mTRF) in audiovisual and audio conditionsat enrollment
Comparison of the 40Hz Auditory steady-state responses (ASSR) between participants with or without GJB2 variantat enrollment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026