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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorRestorear Devices LLC

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

116 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Restorear Devices LLC

Lead sponsor

University of Miami

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator