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

RecruitingNAAges 18 Years - 55 YearsAllRestorear Devices LLC
NCT06729632 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adults aged 18-55 years old at the time of signing the consent form * Fluency in English Exclusion Criteria: * Abnormal tympanometric findings * Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only) * Significant history of noise exposure (Non-firefighters only) * Temporomandibular joint disorder * Otologic pathologies (including, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity * Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions * Active hearing aid users * Adults unable to consent
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What it tests

  • Cold pack-delivered mild therapeutic hypothermia
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Where

1 site
University of Miami
Miami, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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