Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss (HBD-RCT)
17 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
236
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Zhili Wang
- Numéro de téléphone: +86-21-53314064
- E-mail: zhili_w@163.com
Lieux d'étude
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Shanghai, Chine
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011
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Contact:
- Zhili Wang Zhili Wang Zhili Wang
- Numéro de téléphone: +86-21-53314064
- E-mail: zhili_w@163.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Distortion Product Otoacoustic Emissions (DPOAE) Amplitude and Signal-to-Noise Ratio
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Chaise d'étude: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
31 août 2026
Achèvement primaire (Estimé)
31 août 2028
Achèvement de l'étude (Estimé)
31 août 2028
Dates d'inscription aux études
Première soumission
31 juillet 2026
Première soumission répondant aux critères de contrôle qualité
17 août 2026
Première publication (Réel)
19 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
17 août 2026
Dernière vérification
1 mars 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Maladies oto-rhino-laryngologiques
- Troubles des sensations
- Maladies de l'oreille
- Perte d'audition
- Troubles auditifs
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Perte auditive, bilatérale
- Équipement et fournitures
- Équipement et fournitures électriques
- Appareils électroniques portables
- Aides sensorielles
- Aides auditives
Autres numéros d'identification d'étude
- SH9H-2026-T165
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Délai de partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .