Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Restorear Devices LLC
116 participants
Dec 19, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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)
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NCT06729632