RecruitingNCT07509788

Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Implants

Sponsor

Guangdong Provincial People's Hospital

Enrollment

360 participants

Start Date

Oct 1, 2025

Study Type

OBSERVATIONAL

Conditions

Cochlear Implant Users Cochlear Hearing Loss

Summary

This 5-year (2025-2030) prospective observational cohort study aims to recruit 360 participants aged 6-18 years, categorized into three groups: normal-hearing controls, unilateral listeners (unilateral cochlear implantation), and bilateral listeners (bilateral cochlear implantation or bimodal stimulation). At baseline, all participants will undergo comprehensive evaluations, including audiological testing (speech recognition and spectral/temporal resolution), cognitive assessment (WISC and prefrontal resting-state functional connectivity), and social adaptability measurement. Centrally, listening effort will be quantified through an innovative multimodal approach that synchronously records pupil diameter changes and cortical hemodynamic signals via functional near-infrared spectroscopy (fNIRS) during tasks of varying difficulty, objectively reflecting the cognitive resources exerted for speech processing. Through a 3-year longitudinal follow-up, this study seeks to elucidate how different auditory input modes influence children's listening effort, cognitive development, and social adaptation, ultimately providing a robust scientific foundation for optimizing clinical rehabilitation strategies.

Eligibility

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria14

Age: 6-18 years.
Vision: Normal or corrected-to-normal vision.
Comprehension: Ability to understand and follow the experimental instructions.
Consent: Parents or legal guardians have been informed of the study details and have provided written informed consent.
Group-Specific Requirements
Normal Control (NC) Group:
Bilateral pure-tone average (PTA) at 250, 500, 1000, 2000, and 4000 Hz $\\le 30$ dB HL.2.
Bilateral Listening Group:
Bilateral severe-to-profound sensorineural hearing loss.
Bilateral cochlear implantation (CI) OR unilateral CI with a contralateral hearing aid (bimodal stimulation).
Good speech perception abilities, defined as a Categories of Auditory Performance-II (CAP-II) score \>5.
Unilateral Listening Group:
Bilateral severe-to-profound sensorineural hearing loss.
Unilateral CI without the use of a contralateral hearing aid.

Exclusion Criteria1

Diagnosed neurological or psychiatric disorders. 2.Failure to obtain informed consent from legal guardians. 3.Any other condition that, in the opinion of the investigator, renders the participant unsuitable for the study.

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