Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Recruiting now · Not applicable
Conditions studied: Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia, Cooling, Occupational Exposure, Occupational Health, Hidden Hearing Loss
In brief
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 facts
- Study ID
- NCT06729632
- Run by
- Restorear Devices LLC
- People needed
- 116
- Starts
- 2024-12-19
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Adults aged 18-55 years old at the time of signing the consent form
- Fluency in English
You may not qualify if…
- 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
Where it is running
- University of Miami — Miami, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.