Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss (HBD-RCT)
Effects of Hearing Aid Intervention on Brain and Language Development in Children With Bilateral Mild Hearing Loss: A Multicenter Randomized Controlled Trial
This is a multicenter, prospective, randomized controlled clinical trial to evaluate the effects of hearing aid intervention on brain and language development in children with bilateral mild sensorineural hearing loss.
Eligible participants will be randomly assigned (1:1) to either the hearing aid intervention group or the control group.
The primary outcome is the general developmental quotient of the Griffiths Development Scales-Chinese Edition (GDS-C) at 12 months.
Secondary outcomes include auditory and speech development, language development, adaptive behavior, and brain structure and function assessed by MRI.
Follow-up assessments will be conducted at baseline, 6 months, and 12 months.
研究概览
研究类型
介入性
注册 (估计的)
236
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Zhili Wang
- 电话号码：+86-21-53314064
- 邮箱：zhili_w@163.com
学习地点
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Shanghai、中国
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011
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接触：
- Zhili Wang Zhili Wang Zhili Wang
- 电话号码：+86-21-53314064
- 邮箱：zhili_w@163.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- Age: ≥0.5 years and <4 years
- Diagnosed with bilateral mild sensorineural hearing loss by objective hearing tests: bilateral click-ABR ≥35 dB nHL and ≤50 dB nHL, with bilateral type A tympanogram (including As/Ad type) on acoustic immittance testing
- Without previous hearing aid intervention
Exclusion Criteria:
- Premature and low birth weight infants: gestational age less than 37 weeks, or birth weight below 2500 grams
- Participants diagnosed with enlarged vestibular aqueduct (EVA) by imaging (CT, MRI) or genetic testing
- Participants with complicated medical problems or significant disabilities affecting growth and development (such as autism, recurrent epilepsy, severe heart disease requiring multiple surgeries, etc.) and considered unsuitable for this study by the investigators
- Families who refused to participate in this study, or have already decided whether the participant will wear hearing aids or not (refused to randomization).
- Participants who refused/was unable to undergo study assessments as scheduled.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Hearing-aid intervention
Participants in the hearing-aid intervention group will receive standardized bilateral fitting of behind-the-ear (BTE) hearing aids, and their parents will be instructed to ensure consistent daily use for 12 months and be provided with essential knowledge regarding hearing aid maintenance and proper usage.
In addition, the same hearing-care education sessions will also be delivered to this group.
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Bilateral BTE hearing aids will be uniformly provided by the project team and fitted and verified by experienced audiologists at participating sites, with settings adjusted to achieve optimal hearing status according to individual needs.
The devices will be selected from mainstream BTE hearing aid brands and models that are already commercially available in China and widely used in pediatric populations.
Standardized educational sessions covering children hearing and speech development, pediatric hearing care, routine monitoring and detection, and appropriate family support and parent-child interaction delivered by trained researchers during each follow-up visit.
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其他：Hearing-care education
Participants in the hearing-care education control group will not receive hearing aids, but will receive standardized hearing-care educational sessions at each follow-up visit.
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Standardized educational sessions covering children hearing and speech development, pediatric hearing care, routine monitoring and detection, and appropriate family support and parent-child interaction delivered by trained researchers during each follow-up visit.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C)
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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The GDS-C was adapted from the 2006 Griffiths Mental Development Scales - Extended Revised (GMDS-ER) and standardized with Chinese norms for children aged 0-8 years.
It evaluates six subdomains: (A) Locomotor, (B) Personal-Social, (C) Language, (D) Eye & Hand Coordination, (E) Performance, and (F) Practical Reasoning.
The General Developmental Quotient (GDQ) is derived as:(developmental age ÷ chronological age) × 100.
Higher scores indicate better overall developmental status.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Including six subscales: Locomotor (A), Personal-Social (B), Language (C), Eye-hand Co-ordination (D), Performance (E), and Practical Reasoning (F).
Each subscale quotient is calculated as (subscale developmental age ÷ chronological age) × 100.
Higher subscale quotients indicate better performance in the specific domain.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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MRI outcomes
大体时间：Assessed at 0 and 12 months.
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Brain structure and function changes evaluated by MRI
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Assessed at 0 and 12 months.
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Auditory Brainstem Response (ABR)
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Electrical potentials recorded with scalp electrodes in response to electrical stimulation of the cochlear nerve.
The ABR threshold will be measured in decibels normal hearing level (dB nHL) for each ear.
Lower thresholds indicate better auditory function.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Behavioral audiometry thresholds (Pure-Tone Audiometry)
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Behavioral audiometry measures the lowest pure tone level children can respond.
Its thresholds will be measured in decibels hearing level (dB HL) for each ear at standard frequencies.
The Pure Tone Average (PTA) will be calculated by the average of four frequencies (0.5, 1, 2, 4 kHz).
Lower thresholds indicate better hearing.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Word Recognition Score
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Measured by percentage of correctly identified words (ranging from 0% to 100%) from standardized Mandarin Chinese word lists, presented in a quiet sound booth.
Higher percentages indicate better speech perception ability.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Categories of Auditory Performance (CAP) Score
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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The Categories of Auditory Performance (CAP) is a hierarchical rating scale assessing real-life auditory functioning.
It comprises 10 categories graded from 0 to 9, where 0 = "cannot detect environmental or speech sounds" and 9 = "able to use the telephone with an unfamiliar speaker in unpredictable situations".
Higher scores indicating better auditory performance.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Speech Intelligibility Rating (SIR) Score
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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The Speech Intelligibility Rating (SIR) is a hierarchical rating scale assessing the intelligibility of a child's speech in everyday communication.
It comprises 5 categories graded from 1 to 5, with higher scores indicating greater speech intelligibility.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Meaningful Auditory Integration Scale (MAIS/IT-MAIS) Score
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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This scale includes the original MAIS version for children aged ≥3 years and the IT-MAIS (Infant-Toddler version) for children <3 years.
It is a parent-report structured interview designed to assess the child's spontaneous auditory responses in everyday environments, consisting of 10 items evaluating three domains: vocalization behavior, alerting to sounds, and deriving meaning from sound.
Each item is scored from 0 to 4, yielding a total score ranging from 0 to 40.
Higher scores indicate better auditory integration ability.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Meaningful Use of Speech Scale (MUSS) Score
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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The Meaningful Use of Speech Scale (MUSS) assesses speech production and communication ability.
It comprises 10 open-ended questions answered by parents/guardians, each scored 0-4).
The total score ranges from 0 to 40, with higher scores indicating better speech use.
Scores are often reported as percentages (score ÷ 40 × 100%).
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Adaptive behavior measured by Adaptive Behavior Assessment System, Second Edition (ABAS-II)
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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The ABAS-II is a comprehensive, norm-referenced assessment of adaptive functioning across multiple skill areas relevant to daily living.
Depending on the respondent form used, it yields a General Adaptive Composite (GAC) as an overall standard score (mean = 100, SD = 15), three domain composite scores (Conceptual, Social, and Practical), and individual skill area scaled scores covering domains such as Communication, Community Use, Functional Academics, Home Living, Health and Safety, Leisure, Self-Care, Self-Direction, Social, Work (where applicable), and Motor.
Higher scores consistently indicating more advanced adaptive functioning.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Distortion Product Otoacoustic Emissions (DPOAE) Amplitude and Signal-to-Noise Ratio
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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DPOAEs were recorded bilaterally at standard frequencies.
For each frequency, the DPOAE amplitude (in dB SPL) and signal-to-noise ratio (SNR, in dB) were obtained.
The amplitude represents the absolute sound pressure level of the distortion product response, while the SNR is the difference between the amplitude and the background noise floor at the same frequency.
Higher amplitude and SNR indicate stronger outer hair cell (OHC)-mediated cochlear amplification and better cochlear function.
A DPOAE response is conventionally considered present (PASS) when the SNR exceeds 6 dB.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Acoustic Immittance
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Acoustic immittance is measured via tympanometry using a 226-Hz probe tone.
Three quantitative parameters are reported: tympanometric peak pressure (measured in daPa), peak compensated static admittance (measured in mmho), and equivalent ear canal volume (measured in mL).
Results are classified as pass or fail based on standardized criteria.
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Family Environment Survey
大体时间：From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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Including basic family environment survey, and Index of Child Care Environment (ICCE)
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From enrollment to 12 months, with assessments at 0, 6, and 12 months.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Hao Wu、Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- 学习椅：Hao Wu、Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月31日
初级完成 (估计的)
2028年8月31日
研究完成 (估计的)
2028年8月31日
研究注册日期
首次提交
2026年7月31日
首先提交符合 QC 标准的
2026年8月17日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月17日
最后验证
2026年3月1日
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- SH9H-2026-T165
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 共享时间框架
The protocol will be available from study initiation, before the first participant is enrolled.
The final version of SAP will be approved before database lock and will be shared 6 months after the primary results are published.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.