Recruiting

Therapeutic Hypothermia

Sponsor:

Restorear Devices LLC

Code:

NCT06729632

Conditions

Noise Exposure

Noise-induced Hearing Loss

Noise; Adverse Effect

Mild Therapeutic Hypothermia

Cooling

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Cold pack-delivered mild therapeutic hypothermia

Study Details

Brief 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).

Conditions

Noise Exposure

Noise-induced Hearing Loss

Noise; Adverse Effect

Mild Therapeutic Hypothermia

Cooling

Study ID

NCT06729632

Start date

Dec 19, 2024

Status verified date

Jul, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

116 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Cold 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.

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. ]
  • Distortion Product Otoacoustic Emissions [ 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. ]
  • Adverse Event Questionnaire [ Time Frame: Immediately post-treatment; 3-hours and 24-hours post-treatment. ]

Central Contacts and Locations

Central contacts

Suhrud M Rajguru, PhD

801-641-8180srajguru@restorear.com

Curtis S King

406-414-6278cking@restorear.com

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Suhrud M Rajguru, PhD

801-641-8180srajguru@restorear.com

Principal Investigator:

Suhrud M Rajguru, PhD

More Information

Sponsor

Restorear Devices LLC

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • hearing preservation
  • hearing loss
  • noise-induced hearing loss
  • noise exposure
  • mild therapeutic hypothermia
  • cooling
  • post-exposure
  • prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Restorear Devices LLC on 2026-07-23.