Effects of Binaural Hearing on Listening Effort and Cognitive Development in Mandarin-speaking Children With Cochlear Implants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Xiong hao
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- spectral - temporally modulated ripple test
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •(All Groups):
- •Diagnosed neurological or psychiatric disorders
- •Absence of informed consent from parent or guardian
- •Other conditions deemed unsuitable for participation by the investigators
研究组 & 干预措施
bilateral listeners
Children with bilateral cochlear implantation or bimodal stimulation-unilateral CI with a contralateral hearing aid
干预措施: Cochlear Implantation (Device)
normal-hearing controls
Children with normal hearing
unilateral listeners
Children with unilateral cochlear implantation
干预措施: Cochlear Implantation (Device)
结局指标
主要结局
spectral - temporally modulated ripple test
时间窗: Baseline , 1 and 3 years.
Spectral ripple thresholds were measured via a 3I-2AFC, one-up/one-down adaptive procedure. Participants identified a target stimulus among two reference stimuli (fixed at 20 RPO). The target started at 0.5 RPO with a 0.2 RPO step size. The final threshold, defined as the average of the last 6 of 10 reversals, indicates spectral resolution-where higher scores reflect better performance
BKB sentence recognition performance in quiet and noise
时间窗: Baseline , 1 and 3 years.
BKB sentences (6-8 characters) based on the daily vocabulary of 4-5-year-olds in Beijing were used. Subjects repeated keywords from each sentence to determine accuracy.Quiet Condition: Scored as the percentage of correct keywords.Noise Condition (BKB-SIN): Uses 10 sentences in 4-talker babble noise (+21 to -6 dB SNR). The 50% recognition threshold (SNR-50) is calculated as:SNR-50 = 23.5 - Total Correct Keywords
the temporal modulation transfer function
时间窗: Baseline , 1 and 3 years.
The temporal modulation transfer function was determined by the modulation detection threshold (MDT) using a 2-AFC, 2-down-1-up procedure. Stimuli consisted of two 1-s broadband noise intervals: one unmodulated and one amplitude-modulated at 100 Hz. The MDT was calculated as the average of the last 6 reversals and expressed as 20log₁₀(mᵢ), where mᵢ is the modulation index. Two tests were averaged per participant, with a third conducted if the difference exceeded 3 dB
Wechsler Intelligence Scale for Children - Fourth Edition
时间窗: Baseline , 1 and 3 years.
The scale provides a comprehensive assessment of cognitive function across four core indices: Verbal Comprehension, Perceptual Reasoning, Working Memory, and Processing Speed.
Functional near-infrared spectroscopy (fNIRS) measures
时间窗: Baseline , 1 and 3 years
Functional near-infrared spectroscopy (fNIRS) was utilized to measure the resting-state functional connectivity (rsFC) of the prefrontal cortex (PFC). The system operated at three wavelengths (780, 805, and 830 nm) with a sampling rate of 13.3 Hz. The optode configuration, comprising 8 sources and 8 detectors with a 3.0-cm inter-optode distance, covered the PFC (localized to the Fp1-F8 regions based on the international 10-20 system).
the Adaptive Behavior Assessment System, Second Edition
时间窗: Baseline , 1 and 3 years
The scale provides a General Adaptive Composite (GAC) score and categorizes adaptive behavior into three core domains: Conceptual Skills: Communication, functional academics, and self-direction. Social Skills: Leisure and social interaction. Practical Skills: Community use, home/school living, health and safety, and self-care. Respondents rate the child based on their ability to perform activities independently when needed and the frequency of those behaviors (Never, Sometimes, or Always).
Changes in pupil diameter
时间窗: Baseline , 1 and 3 years.
Pupil-related data were recorded using the Pupil Core eye-tracking system (Pupil Labs) with default Pupil Capture settings (fixation duration: 80-220 ms; sampling frequency: 120 Hz).Key events, including stimulus playback onset and the oral response prompt, were synchronized. Prior to testing, participants underwent a pupillary dynamic range measurement-comprising 10 seconds of a black screen (maximum diameter) followed by 10 seconds of a white screen (minimum diameter)-to facilitate subsequent data normalization.
Listening Effort level
时间窗: 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
时间窗: 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.
次要结局
- Speech Audiometry(Baseline , 1 and 3 years.)
- Listening-Related Fatigue Assessment(Baseline , 1 and 3 years.)
- Social Adaptability Assessment(Baseline , 1 and 3 years)
研究者
Xiong hao
Clinical Professor
Guangdong Provincial People's Hospital