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

March 28, 2025 updated by: Restorear Devices LLC

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Noise-induced hearing loss (NIHL) is highly prevalent among occupationally at-risk service groups like the military and firefighters, with disabilities that result in significant healthcare burden, negatively impacting performance on duty and quality of life. Exposure to noise can cause permanent threshold shifts (PTS) with accompanying hair cell loss, or temporary threshold shifts (TTS), with no evident hair cell loss. Noise exposure can also result in rapid and permanent loss of synaptic elements and cochlear nerve terminals with irreversible hearing impairment and long-term degeneration of spiral ganglion (SG) cell bodies.

Currently no FDA-approved treatments are available to prevent or treat NIHL. Delivering pharmaceutical compounds over time, identification of safe dosages, and a critical timeframe relative to noise-exposure remain clinically challenging. RestorEar Devices LLC has developed a non-pharmaceutical application of mild therapeutic hypothermia (MTH) to protect residual sensory structures and function of the cochlea. MTH is a proven and well-established therapy for neuroprotection. This approach for MTH application is based on significant prior and on-going research that highlights its utility for residual hearing preservation against cochlear implant surgical trauma, ototoxicity, and noise exposure. With SBIR Phase I support, the investigators have successfully demonstrated that effective non-invasive, non-pharmaceutical therapeutic hypothermia can be delivered to the inner ear sensory structures. The investigators have built, calibrated, and tested ReBoundTM, a headband with cooling gel packs placed in contact with the surface of the mastoid. ReBoundTM delivers MTH safely and repeatedly for up to 30 minutes. In this study, the investigators aim to extend this application to human subjects and test safety and efficacy against NIHL in noise-exposed firefighters and matched controls with the collaboration of researchers at the University of Miami.

Aim 1: Evaluate safety of MTH with ReBoundTM devices. With the first in-human studies, the investigators aim to show that MTH can be safely delivered to the inner ear using ReBound. In a randomized study, non-firefighter control subjects will receive MTH-treatment and normothermia-sham (non-cooled gel pack) through the device alternated over 8 sessions. Subjective assessments and audiologic testing (pure tone audiometry, auditory brainstem responses, distortion product otoacoustic emissions and electrocochleography) pre- and post-treatments will be compared between MTH-treatment and sham in each subject. Results of Aim 1 will support the hypothesis that this approach will deliver therapeutic hypothermia to the cochleae and that repeated application will not negatively affect hearing function in healthy subjects.

Aim 2: Validate efficacy of the ReBoundTM MTH devices for mitigating NIHL in an occupationally at-risk group. Based on strong preliminary results, the investigators hypothesize that acute application of MTH in noise-exposed firefighters will reduce temporary changes in auditory function. Firefighters will be divided equally into two treatment groups, MTH-treatment and normothermia-sham. These treatments will be delivered with ReBound, with and without cooled gel packs, applied post-duty. MTH-treatment will also be applied in an age- and sex-matched control group over the same duration. Baseline hearing function will be measured prior to initiation of the treatment. Treatments and the functional assessments will be repeated quarterly over one year. Temporary and permanent threshold changes in this chronically the noise exposed group of firefighters receiving MTH-treatment will be compared with firefighters receiving sham-treatment and with controls receiving MTH-treatment. MTH-groups will also be sent home with a ReBound band and instructed to use it after noise exposure. Subjective assessments will be sent weekly to these groups to evaluate the use pattern of the device. Results of these studies will firmly establish MTH for mitigating NIHL.

This research will be highly impactful given the significant adverse effects of NIHL, an unmet clinical need, and the high translational potential of MTH for mitigating NIHL.

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami
        • Contact:
          • Michael Hoffer, MD
        • Contact:
        • Contact:
          • Suhrud M Rajguru, PhD
        • Contact:
          • Hillary Snapp, AuD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
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.
Device: 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.
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.
Device: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pure Tone Audiometry (PTA) will be performed in the Safety and Efficacy arms immediately post-treatment. PTA will be performed at baseline and immediately post-treatment in the Safety Arm, 8 times over 4 weeks. In the Efficacy Arms, it will be completed quarterly before and immediately post-treatment.
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.
Distortion Product Otoacoustic Emissions (DPOAE) will be performed in the Safety and Efficacy Arms immediately post-treatment. DPOAE will be performed at baseline and immediately post-treatment in the Safety Arm, 8 times over 4 weeks. In the Efficacy Arms, it will be completed quarterly before and immediately post-treatment.
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.
The 2 question Adverse Event Questionnaire (AEQ) will be administered in both the Safety and Efficacy Arms. It will collect data on any adverse event associated with use of the device.
Immediately post-treatment; 3-hours and 24-hours post-treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Acceptance Questionnaire
Time Frame: Safety Arm: Post-initial treatment and at the end of week 4 post-enrollment; Efficacy Arms: Post-initial treatment and at the end of 12 months
11 question survey about subjective experience and acceptance of the treatment. Includes Likert Scale questions about comfort, likelihood of use of the device, etc.
Safety Arm: Post-initial treatment and at the end of week 4 post-enrollment; Efficacy Arms: Post-initial treatment and at the end of 12 months
Weekly Use Surveys
Time Frame: Weekly, from enrollment to end of treatment at 52 weeks.
Experimental Efficacy Arm and Non-Firefighter Control Arms for Efficacy Study will complete weekly, 3 question survey monitoring the use of the device at home. Firefighters will be asked how many shifts they had that week and how many times they used the device. Non-firefighters will be asked about their noise exposure and device use.
Weekly, from enrollment to end of treatment at 52 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Restorear Devices LLC

Collaborators

University of Miami
National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Principal Investigator: Suhrud M Rajguru, PhD, RestorEar Devices

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC018760
  • 2R44DC018760-02A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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