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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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Yun Li
liyuncmm@126.com
+86-21-53314064
Time Frame
Start Date: 2026-05-20
Estimated Completion Date: 2030-12-31
Participants
Target number of participants: 5000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

This content was sourced from clinicaltrials.gov