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RECRUITING
NCT07509788

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

Sponsor: Guangdong Provincial People's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

360

Start Date

2025-10-01

Completion Date

2030-10-01

Last Updated

2026-04-03

Healthy Volunteers

Yes

Interventions

DEVICE

Cochlear Implantation

unilateral or bilateral cochlear implantation

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China