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.
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
236
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Zhili Wang
- 電話番号：+86-21-53314064
- メール：zhili_w@163.com
研究場所
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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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コンタクト：
- Zhili Wang Zhili Wang Zhili Wang
- 電話番号：+86-21-53314064
- メール：zhili_w@163.com
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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他の：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
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Distortion Product Otoacoustic Emissions (DPOAE) Amplitude and Signal-to-Noise Ratio
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Hao Wu、Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- スタディチェア：Hao Wu、Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月31日
一次修了 (推定)
2028年8月31日
研究の完了 (推定)
2028年8月31日
試験登録日
最初に提出
2026年7月31日
QC基準を満たした最初の提出物
2026年8月17日
最初の投稿 (実際)
2026年8月19日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月19日
QC基準を満たした最後の更新が送信されました
2026年8月17日
最終確認日
2026年3月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SH9H-2026-T165
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有時間枠
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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