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

3. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Hørselstap

Studietype

Observasjonsmessig

Registrering (Antatt)

5000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen

Tar imot friske frivillige

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Etterforskere

Hovedetterforsker: 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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

20. mai 2026

Primær fullføring (Antatt)

31. desember 2030

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

20. mai 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)