Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07739433

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Congenital Hearing Loss Bilateral Cochlear Implants

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

    Time frame: at enrollment

    language composite score is the dependent variable

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

Sponsors and collaborators

Lead sponsor

Institut Pasteur

Industry

Registry information

Acronym: ICO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.