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

3. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Høretab

Undersøgelsestype

Observationel

Tilmelding (Anslået)

5000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: Yun Li
Telefonnummer: +86-21-53314064
E-mail: liyuncmm@126.com

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Barn
Voksen

Tager imod sunde frivillige

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change in Categories of Auditory Performance-II Score Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Change in Parent-Child Interaction Quality Composite Score Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Efterforskere

Ledende efterforsker: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Studiestol: Hao Wu, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. maj 2026

Primær færdiggørelse (Anslået)

31. december 2030

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)