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

April 10, 2026 updated by: Xiong hao

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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).

Description

CI Group Inclusion Criteria:

  1. Aged 6-18 years
  2. Normal vision, including corrected vision
  3. Prelingual deafness with bilateral severe-to-profound sensorineural hearing loss, with unilateral or bilateral cochlear implantation
  4. Good speech perception ability, with Categories of Auditory Performance-II (CAP-II) score of 5 or above
  5. Cooperative with testing, with signed informed consent from parent or guardian

Normal-Hearing Control Group Inclusion Criteria:

  1. Aged 6-18 years
  2. Normal vision, including corrected vision
  3. Bilateral pure-tone average at 250, 500, 1000, 2000, and 4000 Hz of 30 dB HL or less
  4. Cooperative with testing, with signed informed consent from parent or guardian

Exclusion Criteria (All Groups):

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
normal-hearing controls
Children with normal hearing
unilateral listeners
Children with unilateral cochlear implantation
Device: Cochlear Implantation
unilateral or bilateral cochlear implantation
bilateral listeners
Children with bilateral cochlear implantation or bimodal stimulation-unilateral CI with a contralateral hearing aid
Device: Cochlear Implantation
unilateral or bilateral cochlear implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Listening Effort level
Time Frame: Baseline , 1 and 3 years.
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
Time Frame: Baseline , 1 and 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Audiometry
Time Frame: Baseline , 1 and 3 years.
Speech recognition is assessed using Mandarin BKB sentences (6-8 characters per sentence) selected from a daily spoken language corpus of Beijing children aged 4-5 years, covering common sentence patterns relevant to Chinese children's daily communication. Participants repeat keywords from each sentence. Testing is conducted under both quiet and noise conditions. In quiet conditions, BKB scores are calculated as the percentage of correct keywords. In noise conditions, BKB-SIN testing presents 10 sentences at signal-to-noise ratios ranging from +21 to -6 dB (4-talker babble), with SNR-50 determined by the formula: SNR-50 = 23.5 - total correct keywords. All participants complete at least 1 practice list before 2 formal test lists, with scores averaged. Normal-hearing controls and unilateral CI participants complete testing under binaural conditions only, while bilateral CI and bimodal participants complete testing under binaural, left-ear-only, and right-ear-only conditions.
Baseline , 1 and 3 years.
Listening-Related Fatigue Assessment
Time Frame: Baseline , 1 and 3 years.
Listening-related fatigue is measured using the Vanderbilt Fatigue Scale, including both the Child version (VFS-C) and the Parent version (VFS-P). The VFS-C is a 10-item 5-point Likert scale completed by the child, and the VFS-P is completed by the parent or guardian. Both versions assess the child's fatigue experienced during daily listening situations.
Baseline , 1 and 3 years.
Social Adaptability Assessment
Time Frame: Baseline , 1 and 3 years
Social adaptability is assessed using the Chinese version of the Adaptive Behavior Assessment System, Second Edition (ABAS-II), administered via parent interview concurrent with cognitive testing. The scale covers three domains: conceptual skills, including communication, functional academics, and self-direction; social skills, including leisure and social interaction; and practical skills, including community use, home/school living, health and safety, and self-care.
Baseline , 1 and 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectral and Temporal Resolution Tests
Time Frame: Baseline , 1 and 3 years.
Spectral resolution is measured using the Spectral-Temporally Modulated Ripple Test (SMRT), an adaptive three-interval, two-alternative forced-choice paradigm. The ripple discrimination threshold is determined by averaging the last 6 of 10 reversals, with higher scores indicating better spectral resolution. Temporal resolution is measured using the Temporal Modulation Transfer Function (TMTF) test, a two-alternative forced-choice method with a 2-down-1-up adaptive procedure at 100 Hz modulation frequency. The modulation depth detection threshold (MDT) is expressed as 20log₁₀(mᵢ), averaged across 2 tests. For both tests, normal-hearing controls and unilateral CI participants complete testing under binaural conditions only, while bilateral CI and bimodal participants complete testing under binaural, left-ear-only, and right-ear-only conditions.
Baseline , 1 and 3 years.
Resting-State Brain Functional Scanning
Time Frame: Baseline , 1 and 3 years.
Resting-state functional connectivity (rsFC) is measured using functional near-infrared spectroscopy (fNIRS) while participants watch a 5-minute "Inscapes" video (abstract geometric animations designed for children). Cortical hemodynamic signals are recorded and rsFC is calculated across channel pairs of interest, serving as a neurophysiological marker of executive function development.
Baseline , 1 and 3 years.
Speech Development Assessment
Time Frame: Baseline , 1 and 3 years.
Speech development is assessed using two structured parent/guardian interview scales. The Meaningful Auditory Integration Scale (MAIS) evaluates vocalization, sound awareness, and sound comprehension in daily life. The Meaningful Use of Speech Scale (MUSS) evaluates speech production including vocal communication, speech communication ability, and speech communication skills, scored 0-4 per item (total 40 points), reported as percentage scores.
Baseline , 1 and 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiong hao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2025

Primary Completion (Estimated)

October 1, 2030

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

March 22, 2026

First Submitted That Met QC Criteria

March 29, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2026-125-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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