Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Phase
Observational
Started
2026-05-20
Last updated
2026-06-04
Condition(s) studied
Hearing Loss
Study 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.
Eligibility
Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Change in Categories of Auditory Performance-II Score — 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.
Change in Speech Intelligibility Rating Score — 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.
Change in MRI-derived Brain Development Deviation Composite Score — 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.
Trial sites (1)
Facility
City
Region
Status
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
China
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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