Hearing and Brain Development Cohort in Children and Adolescents

NCT07625462 | Recruiting

• 1 other identifier: HBD-Cohort
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (3)

• Change in Categories of Auditory Performance-II Score

  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

  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

  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

Secondary Outcomes (4)

• Change in Parent-Child Interaction Quality Composite Score

  From baseline to 24-month follow-up

• Change in Griffiths Mental Development Scales General Development Score

  From baseline to 24-month follow-up

• Change in Ages and Stages Questionnaires: Social-Emotional, Second Edition Total Score

  From baseline to 24-month follow-up

• Change in Adaptive Behavior Assessment System, Second Edition General Adaptive Composite Score

  From baseline to 24-month follow-up

Study Arms (6)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Inability to cooperate with study testing procedures.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, 200011, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hao Wu

  Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

• Hao Wu

  Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Central Study Contacts

Yun Li

CONTACT

+86-21-53314064; liyuncmm@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 4, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The IPD will be available beginning 6 months after study completion.
• Access Criteria: Detailed data are available upon reasonable request.

Locations

CN (1)