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Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss

Study acronym: HBD-RCT
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 30 days later Aug 31, 2028 → Sep 30, 2028
See other at-risk trials from Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University to Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University Show 6 more changesShow less
    • Start date: Aug 31, 2026 to Sep 30, 2026
    • Primary and study completion pushed from Aug 31, 2028 to Sep 30, 2028
    • Trial sites expanded: 1 → 12 locations
    • Enrollment target: 236 to 258
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 9 of 10 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, prospective, randomized controlled clinical trial to evaluate the effects of hearing aid intervention on brain and language development in children with bilateral mild sensorineural hearing loss. Eligible participants will be randomly assigned (1:1) to either the hearing aid intervention group or the control group. The primary outcome is the general developmental quotient of the Griffiths Development Scales-Chinese Edition (GDS-C) at 12 months. Secondary outcomes include auditory and speech development, language development, adaptive behavior, and brain structure and function assessed by MRI. Follow-up assessments will be conducted at baseline, 6 months, and 12 months.
Trial Details
NCT Number NCT07774728
Lead Sponsor Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions
(from sponsor)		 Hearing Loss, Bilateral
Related terms Hearing Loss, Bilateral
Enrollment 258 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov