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Clinical Trials in the USA / NCT06729632
Recruiting Not applicable

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

NCT06729632 · tracked via the Priya Life Science USA tracker
Sponsor
Restorear Devices LLC
Phase
Not applicable
Started
2024-12-19
Last updated
2026-07-23

Condition(s) studied

Noise ExposureNoise-induced Hearing LossNoise; Adverse EffectMild Therapeutic HypothermiaCoolingOccupational ExposureOccupational HealthHidden Hearing Loss

Investigational drug(s) / intervention(s)

Cold pack-delivered mild therapeutic hypothermia

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
55 Years
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

Primary outcome measure(s)

  • Pure Tone Audiometry — 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.
  • Distortion Product Otoacoustic Emissions — 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.
  • Adverse Event Questionnaire — 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.

Trial sites (1)

FacilityCityRegionStatus
University of Miami Miami Florida Recruiting

More Restorear Devices LLC trials in the USA

Noninvasive Therapy for Tinnitus Recruiting
External Therapy for Tinnitus Management Recruiting
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06729632 on ClinicalTrials.gov ↗ ← All trials in the USA