Hearing and Brain Development Cohort in Children and Adolescents
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hearing Loss. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Primary outcome measures
- Change in Categories of Auditory Performance-II Score [Time frame: From baseline to 24-month follow-up]
- Change in Speech Intelligibility Rating Score [Time frame: From baseline to 24-month follow-up]
- Change in MRI-derived Brain Development Deviation Composite Score [Time frame: From baseline to 24-month follow-up]
Secondary outcome measures (4)
- Change in Parent-Child Interaction Quality Composite Score [Time frame: From baseline to 24-month follow-up]
- Change in Griffiths Mental Development Scales General Development Score [Time frame: From baseline to 24-month follow-up]
- Change in Ages and Stages Questionnaires: Social-Emotional, Second Edition Total Score [Time frame: From baseline to 24-month follow-up]
- Change in Adaptive Behavior Assessment System, Second Edition General Adaptive Composite Score [Time frame: From baseline to 24-month follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07625462 · HBD-Cohort