Actively Recruiting
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Led by Restorear Devices LLC · Updated on 2025-04-02
116
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
Sponsors
R
Restorear Devices LLC
Lead Sponsor
U
University of Miami
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-55 years old at the time of signing the consent form
- Fluency in English
You will not qualify if you...
- 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 acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
- Current medical, pharmacologic, or therapeutic treatment for tinnitus or other otologic conditions
- Active hearing aid users
- Adults unable to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
S
Suhrud M Rajguru, PhD
CONTACT
C
Curtis S King
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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