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Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Sponsor: Restorear Devices LLC
Summary
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).
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
116
Start Date
2024-12-19
Completion Date
2026-12-31
Last Updated
2025-04-02
Healthy Volunteers
Yes
Conditions
Interventions
Cold pack-delivered mild therapeutic hypothermia
Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBoundRx.
Locations (1)
University of Miami
Miami, Florida, United States