Actively Recruiting

Age: 6Years - 18Years
All Genders
Healthy Volunteers
ID07509788

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

Led by Xiong hao · Updated on 2026-04-15

360

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how listening effort affects brain development and daily life in school-aged children between 6 and 18 years old who use cochlear implants (CIs) for severe hearing loss. The study compares children with CIs to those with normal hearing to understand if extra mental effort to listen impacts their cognitive growth, social skills, and quality of life over three years. It also explores whether listening with two ears reduces this effort compared to one ear only. Participants are grouped as children with normal hearing, those with one cochlear implant, and those with two implants or one implant plus a hearing aid. During the study, children will complete hearing tests, wear non-invasive devices like a functional near-infrared spectroscopy (fNIRS) headset and eye-tracking glasses to measure brain activity and pupil changes while listening, and take age-appropriate memory and thinking tests. Parents or guardians will answer questions about social skills and daily communication. The same assessments will be repeated at one year and three years after the first visit. Children will continue their usual medical and rehabilitation care throughout the study. Researchers will monitor listening effort levels and cognitive function at baseline, one year, and three years. They will also assess speech understanding, listening-related fatigue, and social adaptability at these times. The study will enroll about 360 children at Guangdong Provincial People's Hospital, aiming to provide insights for better support and rehabilitation strategies for children with cochlear implants.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 6 to 18 years
  • Normal vision, including corrected vision
  • For cochlear implant group: prelingual deafness with severe-to-profound bilateral sensorineural hearing loss and unilateral or bilateral cochlear implantation
  • Good speech perception ability with a Categories of Auditory Performance-II (CAP-II) score of 5 or above
  • Ability to cooperate with testing and signed informed consent from parent or guardian
  • For normal hearing group: bilateral pure-tone average hearing of 30 dB HL or less at 250, 500, 1000, 2000, and 4000 Hz
  • Signed informed consent from parent or guardian
Not Eligible

You will not qualify if you...

  • Diagnosed neurological or psychiatric disorders
  • Lack of informed consent from parent or guardian
  • Any condition deemed unsuitable for participation by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - 3 years

Participants are observed over time to assess listening effort, cognitive development, speech audiometry, listening-related fatigue, and social adaptability.

Assessments at baseline, 1 year, and 3 years

Trial Site Locations

Total: 1 location

1

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

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Research Team

Z

Zhuoyi Chen MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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