About this trial
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 criteria
Qualifiers
Adults aged 18-55 years old at the time of signing the consent form
Fluency in English
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cold pack-delivered mild therapeutic hypothermia
Treatment groups
Sponsors and collaborators
Restorear Devices LLC
Lead sponsor
University of Miami
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator