Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss (HBD-RCT)
17 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
236
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Zhili Wang
- Número de teléfono: +86-21-53314064
- Correo electrónico: zhili_w@163.com
Ubicaciones de estudio
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Shanghai, Porcelana
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011
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Contacto:
- Zhili Wang Zhili Wang Zhili Wang
- Número de teléfono: +86-21-53314064
- Correo electrónico: zhili_w@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Otro: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Children overall development, as measured by General Developmental Quotient (GDQ) from the Griffiths Development Scales - Chinese Edition (GDS-C)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Griffiths Development Scales-Chinese Edition (GDS-C) subscale quotients
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Distortion Product Otoacoustic Emissions (DPOAE) Amplitude and Signal-to-Noise Ratio
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Investigadores
- Investigador principal: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
- Silla de estudio: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
31 de agosto de 2026
Finalización primaria (Estimado)
31 de agosto de 2028
Finalización del estudio (Estimado)
31 de agosto de 2028
Fechas de registro del estudio
Enviado por primera vez
31 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2026
Publicado por primera vez (Actual)
19 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de marzo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Otorrinolaringológicas
- Trastornos sensoriales
- Enfermedades del oído
- Pérdida de la audición
- Trastornos de la audición
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Pérdida Auditiva, Bilateral
- Equipos y suministros
- Equipos y suministros eléctricos
- Dispositivos electrónicos portátiles
- Ayudas sensoriales
- Audífonos
Otros números de identificación del estudio
- SH9H-2026-T165
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Marco de tiempo para compartir 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .