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

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).

NCT Number	NCT06729632
Lead Sponsor	Restorear Devices LLC Collaborators: University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions	Noise Exposure, Noise-induced Hearing Loss, Noise; Adverse Effect, Mild Therapeutic Hypothermia, Cooling, Occupational Exposure, Occupational Health, Hidden Hearing Loss
Enrollment	116 participants
Start Date	2024-12-19
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-09-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-23