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Hearing and Brain Development Cohort in Children and Adolescents (HBD-Cohort)

2026年6月3日更新者：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.

調査の概要

状態

募集

条件

難聴

研究の種類

観察的

入学 (推定)

5000

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：Yun Li
電話番号：+86-21-53314064
メール：liyuncmm@126.com

研究場所

中国
- - Shanghai、中国、200011
    - 募集
    - Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
    - コンタクト：
      
      Yun Li
      
      電話番号：+86-21-53314064
      
      メール：liyuncmm@126.com

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
大人

健康ボランティアの受け入れ

はい

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

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

グループ/コホートの数

コホートと介入

グループ/コホート
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.).
CI Participants suitable for unilateral or bilateral cochlear implantation, without gene therapy treatment or auditory brainstem implantation.
ABI Participants suitable for unilateral or bilateral auditory brainstem implantation.
GT Participants suitable for gene therapy treatment.
FU Participants with hearing loss who do not receive any intervention.
NH Control Participants with normal hearing who are enrolled as healthy controls.

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
Change in Categories of Auditory Performance-II Score 時間枠：From baseline to 24-month follow-up	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.	From baseline to 24-month follow-up
Change in Speech Intelligibility Rating Score 時間枠：From baseline to 24-month follow-up	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.	From baseline to 24-month follow-up
Change in MRI-derived Brain Development Deviation Composite Score 時間枠：From baseline to 24-month follow-up	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.	From baseline to 24-month follow-up

二次結果の測定

結果測定	メジャーの説明	時間枠
Change in Parent-Child Interaction Quality Composite Score 時間枠：From baseline to 24-month follow-up	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.	From baseline to 24-month follow-up
Change in Griffiths Mental Development Scales General Development Score 時間枠：From baseline to 24-month follow-up	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.	From baseline to 24-month follow-up
Change in Ages and Stages Questionnaires: Social-Emotional, Second Edition Total Score 時間枠：From baseline to 24-month follow-up	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.	From baseline to 24-month follow-up
Change in Adaptive Behavior Assessment System, Second Edition General Adaptive Composite Score 時間枠：From baseline to 24-month follow-up	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.	From baseline to 24-month follow-up

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。

スポンサー

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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5月20日

一次修了 (推定)

2030年12月31日

研究の完了 (推定)

2030年12月31日

試験登録日

最初に提出

2026年5月20日

QC基準を満たした最初の提出物

2026年6月3日

最初の投稿 (実際)

2026年6月4日

学習記録の更新

投稿された最後の更新 (実際)