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

NCT07739433 | Not Yet Recruiting

• 1 other identifier: 2025-067
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Congenital Hearing Loss; Bilateral Cochlear Implants

Outcome Measures

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

  at enrollment

Secondary Outcomes (4)

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

  at enrollment

• peak frequencies of the EEG resting-state oscillations

  at enrollment

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

  at enrollment

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

  at enrollment

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 31, 2026

Record last verified: 2026-07