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Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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
About the study
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).
What is being tested
- Cold pack-delivered mild therapeutic hypothermia (device)
Sponsor: Restorear Devices LLC · Participants: 116 · Started: Dec 19, 2024
Contact the study team
- Suhrud M Rajguru, PhD · Phone: 801-641-8180
- Curtis S King · Phone: 406-414-6278
Official record on ClinicalTrials.gov — NCT06729632
Locations in the U.S.
| Florida | University of Miami, Miami |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.