Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Implants
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 18 years old?
Source: NCT07509788, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Xiong hao
- Trial code
- NCT07509788
- Record updated
- 15 April 2026
- Original description
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:Read full original descriptionShow less
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.
Exclusion: Diagnosed neurological or psychiatric disorders; Other conditions deemed unsuitable for participation by the investigators; Absence of informed consent from parent or guardian.
CI Group Inclusion Criteria:; 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; Normal-Hearing Control Group Inclusion Criteria:; 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.