Cochlear Hearing Loss, Cochlear Implant Users
Conditions
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.
Interventions
None listed
Sponsors
Xiong hao
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Listening Effort level | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Audiometry | 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. |
| Listening-Related Fatigue Assessment | 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. |
| Social Adaptability Assessment | 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. |
Countries
China
Contacts
CONTACTZhuoyi Chen MD
Outcome results
None listed