Cochlear Implant UsersNCT07509788
Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Implants
An observational study of Cochlear Implant Users and Cochlear Hearing Loss, run by Xiong hao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cochlear Implant Users, Cochlear Hearing Loss
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2025to 1 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
None listed.
Who cannot join
- Diagnosed neurological or psychiatric disorders
- Absence of informed consent from parent or guardian
- Other conditions deemed unsuitable for participation by the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong
Zhuoyi Chen MD, +86 18737552662, 18737552662@163.com
About this study
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?
Read more
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 Implant Users, Cochlear Hearing Loss
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline , 1 and 3 years
Secondary outcomes (3)
Speech Audiometry
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.
Measured: Baseline , 1 and 3 years.
Listening-Related Fatigue Assessment
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.
Measured: Baseline , 1 and 3 years.
Social Adaptability Assessment
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.
Measured: Baseline , 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Oct 2025
- Primary completion1 Oct 2030 (estimated)
- Study completion1 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cochlear Implant UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiong hao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiong hao, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509788
- Sponsor's protocol ID
- KY2026-125-01
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Implants
- ClinicalTrials.gov ID
- NCT07509788
- Acronym / sponsor ID
- KY2026-125-01
- Conditions
- Cochlear Implant Users, Cochlear Hearing Loss
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Xiong haoUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Oct 2030 (estimated)
- Study completion
- 1 Oct 2030 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Diagnosed neurological or psychiatric disorders
- Absence of informed consent from parent or guardian
- Other conditions deemed unsuitable for participation by the investigators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Speech Audiometry
Time frame: Baseline , 1 and 3 years.
Listening-Related Fatigue Assessment
Time frame: Baseline , 1 and 3 years.
Social Adaptability Assessment
Time frame: Baseline , 1 and 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implant Users and Cochlear Hearing Loss, run by Xiong hao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhuoyi Chen MD (+86 18737552662, 18737552662@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Listening Effort level (time frame: Baseline , 1 and 3 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.