RecruitingNot ApplicableNCT06729632

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


Sponsor

Restorear Devices LLC

Enrollment

116 participants

Start Date

Dec 19, 2024

Study Type

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cold pack-delivered mild therapeutic hypothermia for people with cooling, hidden hearing loss, and other related conditions. The study is currently recruiting participants at 1 location.

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

DEVICECold 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

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NCT06729632


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