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

Part of paid clinical trials in Miami, Florida.

Sponsor
Restorear Devices LLC
Study ID
NCT06729632
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Dec 19, 2024
Status verified
Mar 2025
Primary completion
Jun 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Safety Arm
    Non-firefighter control subjects will receive MTH-treatment and normothermia-sham through the device alternated over 8 sessions. Subjective assessments and audiologic testing pre- and post-treatments will be compared between MTH-treatment and sham in each subject. n=24.
  • Experimental: Efficacy Arm 1 - Treatment
    Firefighters will receive hypothermia treatment delivered with ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Temporary and permanent threshold changes in this chronically noise exposed group of firefighters receiving MTH-treatment will be compared with firefighters receiving sham-treatment and with controls receiving MTH-treatment. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24.
  • No Intervention: Efficacy Arm 2 - Non-Therapeutic
    Firefighters will receive non-therapeutic "treatment" delivered with normothermic ReBound devices, applied post-work shift. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. n=24.
  • Active Comparator: Efficacy Arm 3 - Control
    Age- and sex-matched non-firefighter control group will receive MTH-treatment quarterly over the same duration. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and functional assessments will be repeated quarterly over one year. Subjects in this group will also be sent home with a device to use after noise exposure during the study period. They will complete weekly, remote surveys collecting data on their noise exposure and device use. n=24.

Primary Outcome Measure

Pure Tone Audiometry [ Time Frame: Safety Arm: Twice per week, pre- and post- treatment, to the end of treatment at 4 weeks. Efficacy Arms: Every 3 months, pre- and post-treatment, for 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Suhrud M Rajguru, PhD
[email protected]
801-641-8180
Suhrud M Rajguru, PhD (PRINCIPAL_INVESTIGATOR)
Hillary Snapp, AuD (SUB_INVESTIGATOR)
Michael Hoffer, MD (SUB_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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