Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Recruiting
N/A
Interventional Study
Noise Exposure
Noise-induced Hearing Loss
Noise; Adverse Effect
Mild Therapeutic Hypothermia
Cooling
Occupational Exposure
Occupational Health
Hidden Hearing Loss
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 116 (estimated)
- Sponsor
- Restorear Devices LLC · Industry
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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 fi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adults aged 18-55 years old at the time of signing the consent form
* Fluency in English
Exclusion Criteria:
* Abnormal tympanometric findings
* Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)
* Significant history of noise exposure (Non-firefighters …
Contacts