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

3. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Schwerhörigkeit

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

5000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Name: Yun Li
Telefonnummer: +86-21-53314064
E-Mail: liyuncmm@126.com

Studienorte

China
- - Shanghai, China, 200011
    - Rekrutierung
    - Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
    - Kontakt:
      
      Yun Li
      
      Telefonnummer: +86-21-53314064
      
      E-Mail: liyuncmm@126.com

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

Kind
Erwachsene

Akzeptiert gesunde Freiwillige

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Anzahl der Gruppen / Kohorten

Kohorten und Interventionen

Gruppe / Kohorte
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change in Categories of Auditory Performance-II Score Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Change in Parent-Child Interaction Quality Composite Score Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

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

Ermittler

Hauptermittler: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Studienstuhl: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. Mai 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2030

Studienabschluss (Geschätzt)

31. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

20. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

4. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)