Hearing Loss Clinical Trials

Find Hearing Loss Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
China
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Contact Information
Primary
Zhuoyi Chen MD
18737552662@163.com
+86 18737552662
Time Frame
Start Date: 2025-10-01
Estimated Completion Date: 2030-10-01
Participants
Target number of participants: 360
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Xiong hao

This content was sourced from clinicaltrials.gov

Similar Clinical Trials