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

NCT07509788 | Recruiting

• 1 other identifier: KY2026-125-01
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn how listening effort affects brain development and daily life in school-aged children (ages 6-18) who use cochlear implants (CIs), which are electronic devices surgically placed in the ear to help children with severe hearing loss hear sounds. The main questions it aims to answer are: Do children with CIs use more mental energy to listen than children with normal hearing, and does this extra effort slow their brain development over time? Does listening with two ears (bilateral CIs or a CI plus a hearing aid) reduce listening effort compared to listening with one ear only? How does listening effort affect children's ability to get along with others and adapt to daily life? Researchers will compare children with CIs to children with normal hearing to see if differences in listening effort lead to differences in cognitive development, social skills, and quality of life over 3 years. Participants will: Complete hearing tests to measure how well they understand speech in quiet and noisy settings Wear a functional near-infrared spectroscopy (fNIRS) headset and eye-tracking glasses during a short listening task (about 15-40 minutes) so researchers can measure brain activity and pupil size changes - these are safe, painless, and non-invasive ways to see how hard the brain is working to listen Take thinking and memory tests appropriate for their age Have a parent or guardian answer questions about their child's social skills and daily communication Return for the same set of tests at 1 year and 3 years after the first visit This study does not involve any new treatment or change to a child's current care. All children will continue their regular medical and rehabilitation plans. The study aims to enroll 360 children (120 with normal hearing and 240 with cochlear implants) at Guangdong Provincial People's Hospital in China. Results may help doctors better understand when children with CIs need extra support and how to improve rehabilitation strategies.

Conditions

Cochlear Hearing Loss; Cochlear Implant Users

Outcome Measures

Primary Outcomes (2)

• Listening Effort level

  Listening effort is measured synchronously during listening tasks using a multimodal approach, including pupillometry metrics (peak pupil dilation and mean pupil dilation, expressed as percentage of dynamic range) and fNIRS cortical hemodynamic metrics (HbDiff activation levels in bilateral inferior frontal gyrus and superior temporal gyrus regions). For participants with bilateral listening devices (bilateral CIs or bimodal stimulation), listening effort is measured under both better-ear-only and binaural listening conditions. Assessed at baseline, 1-year follow-up, and 3-year follow-up.

  Baseline , 1 and 3 years.

• Cognitive Function Assessment

  Cognitive function is assessed using the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV), including four index scores - Verbal Comprehension, Perceptual Reasoning, Working Memory, and Processing Speed - as well as the Full-Scale Intelligence Quotient (FSIQ). Assessed at baseline, 1-year follow-up, and 3-year follow-up.

  Baseline , 1 and 3 years

Secondary Outcomes (3)

• Speech Audiometry

  Baseline , 1 and 3 years.

• Listening-Related Fatigue Assessment

  Baseline , 1 and 3 years.

• Social Adaptability Assessment

  Baseline , 1 and 3 years

Other Outcomes (3)

• Spectral and Temporal Resolution Tests

  Baseline , 1 and 3 years.

• Resting-State Brain Functional Scanning

  Baseline , 1 and 3 years.

• Speech Development Assessment

  Baseline , 1 and 3 years.

Study Arms (3)

normal-hearing controls

Children with normal hearing

unilateral listeners

Children with unilateral cochlear implantation

bilateral listeners

Children with bilateral cochlear implantation or bimodal stimulation-unilateral CI with a contralateral hearing aid

Interventions

Cochlear Implantation

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We aim to recruit 360 participants aged 6-18 years, categorized into three groups: a normal-hearing (NH) control group, a unilateral listening group (unilateral cochlear implantation, UCI), and a bilateral listening group (comprising bilateral cochlear implantation or bimodal stimulation-unilateral CI with a contralateral hearing aid).

You may qualify if:

• Aged 6-18 years
• Normal vision, including corrected vision
• Prelingual deafness with bilateral severe-to-profound sensorineural hearing loss, with unilateral or bilateral cochlear implantation
• Good speech perception ability, with Categories of Auditory Performance-II (CAP-II) score of 5 or above
• Cooperative with testing, with signed informed consent from parent or guardian
• Aged 6-18 years
• Normal vision, including corrected vision
• Bilateral pure-tone average at 250, 500, 1000, 2000, and 4000 Hz of 30 dB HL or less
• Cooperative with testing, with signed informed consent from parent or guardian

You may not qualify if:

• Diagnosed neurological or psychiatric disorders
• Absence of informed consent from parent or guardian
• Other conditions deemed unsuitable for participation by the investigators

Sponsors & Collaborators

• Xiong hao: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Zhuoyi Chen MD

CONTACT

+86 18737552662; 18737552662@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 3, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

CN (1)