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

Restorear Devices LLC · with University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD) · NCT06729632

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
116
US sites recruiting
1
Study start
December 19, 2024
Record last updated
July 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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:

  • To test the safety and best duration for use for a new hypothermia device.
  • 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).

Being studied: Cold pack-delivered mild therapeutic hypothermia

Conditions: Noise Exposure; Noise-induced Hearing Loss; Noise; Adverse Effect; Mild Therapeutic Hypothermia; Cooling; Occupational Exposure; Occupational Health; Hidden Hearing Loss

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 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

Recruiting US locations

  • University of Miami

    Miami, FL 33136

    Site contact: Suhrud M Rajguru, PhD · 801-641-8180 · srajguru@restorear.com

Study contacts (from the official record)

  • Suhrud M Rajguru, PhD · 801-641-8180 · srajguru@restorear.com
  • Curtis S King · 406-414-6278 · cking@restorear.com
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Non-Invasive System to Deliver Therapeutic Hypothermia for… (NCT06729632) | Bored Studies