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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline , 1 and 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spectral and Temporal Resolution Tests | 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. |
CI Group Inclusion Criteria:
Normal-Hearing Control Group Inclusion Criteria:
Exclusion Criteria (All Groups):
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhuoyi Chen MD | Contact | +86 18737552662 | 18737552662@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| 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. | 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. | Baseline , 1 and 3 years |
| Baseline , 1 and 3 years. |
| Resting-State Brain Functional Scanning | 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 | 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. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |