RecruitingNot ApplicableNCT06729632

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


Sponsor

Restorear Devices LLC

Enrollment

116 participants

Start Date

Dec 19, 2024

Study Type

INTERVENTIONAL

Summary

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

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria2

  • Adults aged 18-55 years old at the time of signing the consent form
  • Fluency in English

Exclusion Criteria8

  • 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, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
  • Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions
  • Active hearing aid users
  • Adults unable to consent

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Interventions

DEVICECold pack-delivered mild therapeutic hypothermia

Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBoundRx.


Locations(1)

University of Miami

Miami, Florida, United States

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NCT06729632