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Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jun 1, 2026 → Mar 31, 2027
See other at-risk trials from Restorear Devices LLC

Record History

  1. Primary completion pushed from Jun 1, 2026 to Mar 31, 2027
    • Study completion pushed from Dec 31, 2026 to Sep 30, 2027
    v4
  2. Start date: Dec 11, 2024 to Dec 19, 2024
    • Site contact updated
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for preservation of sensory structures in the cochlea after noise exposure. The main aims of the study are: 1. To test the safety and best duration for use for a new hypothermia device. 2. To determine if the hypothermia device helps decrease noise-induced hearing loss in a group of firefighters. Participants will wear the mild therapeutic hypothermia therapy devices immediately after a fire service shift serially over a year. Researchers will compare results from those receiving the therapy to those from a control group (individuals receiving no therapy and a sham therapy).
Trial Details
NCT Number NCT06729632
Lead Sponsor Restorear Devices LLC
Collaborators: University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions
(from sponsor)		 Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia, Cooling, Occupational Exposure, Occupational Health, Hidden Hearing Loss
Related terms Hearing Loss, Hearing Loss, Hidden, Hearing Loss, Noise-Induced
Enrollment 116 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov