Hearing and Brain Development Cohort in Children and Adolescents (HBD-Cohort)
3 de junio de 2026 actualizado por: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
A Longitudinal Cohort Study of Hearing and Brain Development in Children and Adolescents With Hearing Loss Across Different Hearing Management Pathways and in Normal-Hearing Controls
This bidirectional observational cohort study aims to establish a Hearing and Brain Development (HBD) cohort in children and adolescents with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as in a normal-hearing control group.
Participants will undergo longitudinal assessments of hearing, speech, language, neurodevelopment, and multimodal brain function.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Tipo de estudio
De observación
Inscripción (Estimado)
5000
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: Yun Li
- Número de teléfono: +86-21-53314064
- Correo electrónico: liyuncmm@126.com
Ubicaciones de estudio
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Shanghai, Porcelana, 200011
- Reclutamiento
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
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Contacto:
- Yun Li
- Número de teléfono: +86-21-53314064
- Correo electrónico: liyuncmm@126.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
- Adulto
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
The study population consists of children and adolescents aged 0 to 18 years who are evaluated and/or managed at the Department of Otolaryngology-Head and Neck Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine.
The cohort includes participants with hearing loss across different hearing management pathways, including hearing aid fitting, cochlear implantation, auditory brainstem implantation, gene therapy, and follow-up without intervention, as well as a normal-hearing control group.
Descripción
Inclusion Criteria:
- Age no more than 18 years.
- For the HA/CI/ABI/GT/FU groups: behavioral or pure-tone hearing threshold >=20 dB HL, or air-conduction ABR >=35 dB nHL; For the normal-hearing control group: participants diagnosed as normal hearing by experienced physicians.
Exclusion Criteria:
- Inability to cooperate with study testing procedures.
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
Cohortes e Intervenciones
Grupo / Cohorte |
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HA
Participants suitable for unilateral or bilateral hearing aid(s) fitting, without any other intervention methods (cochlear implantation, gene therapy treatment, auditory brainstem implantation, etc.).
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CI
Participants suitable for unilateral or bilateral cochlear implantation, without gene therapy treatment or auditory brainstem implantation.
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ABI
Participants suitable for unilateral or bilateral auditory brainstem implantation.
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GT
Participants suitable for gene therapy treatment.
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FU
Participants with hearing loss who do not receive any intervention.
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NH Control
Participants with normal hearing who are enrolled as healthy controls.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Categories of Auditory Performance-II Score
Periodo de tiempo: From baseline to 24-month follow-up
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The Categories of Auditory Performance-II scale will be used to assess auditory performance.
Scores range from 0 to 9, with higher scores indicating better auditory performance.
Change is calculated as the value at follow-up minus the baseline value.
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From baseline to 24-month follow-up
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Change in Speech Intelligibility Rating Score
Periodo de tiempo: From baseline to 24-month follow-up
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The Speech Intelligibility Rating scale will be used to assess speech intelligibility.
Scores range from 1 to 5, with higher scores indicating better speech intelligibility.
Change is calculated as the value at follow-up minus the baseline value.
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From baseline to 24-month follow-up
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Change in MRI-derived Brain Development Deviation Composite Score
Periodo de tiempo: From baseline to 24-month follow-up
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The MRI-derived Brain Development Deviation Composite Score will be calculated from pre-specified multimodal brain magnetic resonance imaging measures using age-adjusted normative models.
All pre-specified MRI measures will be combined into a single standardized composite score before analysis.
The score summarizes the magnitude of deviation from age-expected brain development.
Higher values indicate greater deviation from age-expected brain development.
Change is calculated as the value at follow-up minus the baseline value.
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From baseline to 24-month follow-up
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Parent-Child Interaction Quality Composite Score
Periodo de tiempo: From baseline to 24-month follow-up
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The Parent-Child Interaction Quality Composite Score will be used to assess parent-child interaction quality based on a pre-specified observational coding scheme.
The composite score summarizes overall interaction quality during recorded parent-child interaction tasks.
Higher scores indicate better parent-child interaction quality.
Change is calculated as the value at follow-up minus the baseline value.
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From baseline to 24-month follow-up
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Change in Griffiths Mental Development Scales General Development Score
Periodo de tiempo: From baseline to 24-month follow-up
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The Griffiths Mental Development Scales will be used to assess general developmental level.
The general development score reflects overall developmental functioning across multiple developmental domains.
Higher scores indicate better general developmental functioning.
Change is calculated as the value at follow-up minus the baseline value.
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From baseline to 24-month follow-up
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Change in Ages and Stages Questionnaires: Social-Emotional, Second Edition Total Score
Periodo de tiempo: From baseline to 24-month follow-up
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The Ages and Stages Questionnaires: Social-Emotional, Second Edition will be used to assess social-emotional development.
Total scores vary by age-specific form, with higher scores indicating greater social-emotional concern.
Change is calculated as the value at follow-up minus the baseline value.
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From baseline to 24-month follow-up
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Change in Adaptive Behavior Assessment System, Second Edition General Adaptive Composite Score
Periodo de tiempo: From baseline to 24-month follow-up
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The Adaptive Behavior Assessment System, Second Edition will be used to assess adaptive behavior.
The General Adaptive Composite score summarizes overall adaptive functioning across daily living, communication, social, and practical adaptive skill areas.
Higher scores indicate better adaptive functioning.
Change is calculated as the value at follow-up minus the baseline value.
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From baseline to 24-month follow-up
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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)
20 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2030
Finalización del estudio (Estimado)
31 de diciembre de 2030
Fechas de registro del estudio
Enviado por primera vez
20 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de junio de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de junio de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HBD-Cohort
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Marco de tiempo para compartir IPD
The IPD will be available beginning 6 months after study completion.
Criterios de acceso compartido de IPD
Detailed data are available upon reasonable request.
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
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