Hearing and Brain Development Cohort in Children and Adolescents (NCT07625462) | Clinical Trial Compass
RecruitingNot Applicable
Hearing and Brain Development Cohort in Children and Adolescents
China5,000 participantsStarted 2026-05-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Categories of Auditory Performance-II Score
Timeframe: From baseline to 24-month follow-up
2
Change in Speech Intelligibility Rating Score
Timeframe: From baseline to 24-month follow-up
3
Change in MRI-derived Brain Development Deviation Composite Score
Timeframe: From baseline to 24-month follow-up
Trial details
NCT IDNCT07625462
SponsorShanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University