Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss (HBD-RCT)
2026년 8월 17일 업데이트: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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.
연구 개요
상태
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정황
연구 유형
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등록 (추정된)
236
단계
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연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Zhili Wang
- 전화번호: +86-21-53314064
- 이메일: zhili_w@163.com
연구 장소
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Shanghai, 중국
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011
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연락하다:
- Zhili Wang Zhili Wang Zhili Wang
- 전화번호: +86-21-53314064
- 이메일: zhili_w@163.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Distortion Product Otoacoustic Emissions (DPOAE) Amplitude and Signal-to-Noise Ratio
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- 연구 의자: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 8월 31일
기본 완료 (추정된)
2028년 8월 31일
연구 완료 (추정된)
2028년 8월 31일
연구 등록 날짜
최초 제출
2026년 7월 31일
QC 기준을 충족하는 최초 제출
2026년 8월 17일
처음 게시됨 (실제)
2026년 8월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 17일
마지막으로 확인됨
2026년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SH9H-2026-T165
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 기간
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .