Auditory and non-auditory effects of noise on health.
Mathias Basner, Wolfgang Babisch, Adrian Davis...
https://pubmed.ncbi.nlm.nih.gov/24183105Actively Recruiting
Phase Not Applicable
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID06729632
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Led by Restorear Devices LLC · Updated on 2025-04-02
116
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
R
Restorear Devices LLC
Lead Sponsor
U
University of Miami
Collaborating Sponsor
AI-Summary
What this Trial Is About
Noise-induced hearing loss (NIHL) is common among people exposed to loud noises at work, such as firefighters and military personnel. This research is studying a new mild therapeutic hypothermia (MTH) device designed to protect the inner ear's sensory structures from damage caused by noise exposure. The study aims to test the safety of the device and how well it protects hearing over time, addressing a major unmet need since no FDA-approved treatments currently exist for NIHL. The study uses the ReBoundTM device, a headband with cooling gel packs that deliver mild therapeutic hypothermia to the inner ear for 30 minutes. Participants include non-firefighter controls and firefighters exposed to noise. Control subjects will alternate between real cooling and sham treatments over eight sessions, while firefighters will receive either the cooling treatment or a non-therapeutic sham after work shifts. Treatments and hearing assessments will be done quarterly over one year. Some participants will use the device at home after noise exposure and complete weekly surveys on device use and noise exposure. Participants will undergo hearing tests such as pure tone audiometry and otoacoustic emissions before and after treatments. Safety will be monitored using adverse event questionnaires immediately and up to 24 hours post-treatment. Weekly surveys will track device acceptance and usage. The study will compare hearing changes in firefighters receiving cooling therapy versus sham treatment and controls. Total participation lasts up to one year with regular evaluations to assess the device's safety and effect on hearing preservation.
CONDITIONS
Brief Title
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Who Can Participate
Age: 18Years - 55Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18-55 years old at the time of signing the consent form
- Fluency in English
You will not qualify if you...
- 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 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 year
Participants receive mild therapeutic hypothermia (cooling) delivered non-invasively to the inner ear structures for 30 minutes using the ReBound device. Firefighters and control participants receive treatments and audiologic assessments quarterly over one year. Participants in treatment groups are also sent home with the device for use after noise exposure and complete weekly remote surveys on device use and noise exposure.
Quarterly visits for treatment and assessments; weekly remote surveys throughout the year
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
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Research Team
S
Suhrud M Rajguru, PhD
C
Curtis S King
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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Published Research Related To This Trial
Hearing loss and cochlear pathology in monkeys after noise exposure.
J E Hawkins, L G Johnsson, W C Stebbins...
https://pubmed.ncbi.nlm.nih.gov/817561Synaptopathy in the noise-exposed and aging cochlea: Primary neural degeneration in acquired sensorineural hearing loss.
Sharon G Kujawa, M Charles Liberman
https://pubmed.ncbi.nlm.nih.gov/25769437Aging after noise exposure: acceleration of cochlear synaptopathy in "recovered" ears.
Katharine A Fernandez, Penelope W C Jeffers, Kumud Lall...
https://pubmed.ncbi.nlm.nih.gov/25972177Prelude: noise-induced tinnitus and hearing loss in the military.
Kurt Yankaskas
https://pubmed.ncbi.nlm.nih.gov/22575206Toward a Differential Diagnosis of Hidden Hearing Loss in Humans.
M Charles Liberman, Michael J Epstein, Sandra S Cleveland...
https://pubmed.ncbi.nlm.nih.gov/27618300Effects of lifetime noise exposure on the middle-age human auditory brainstem response, tinnitus and speech-in-noise intelligibility.
Joaquin T Valderrama, Elizabeth Francis Beach, Ingrid Yeend...
https://pubmed.ncbi.nlm.nih.gov/29913342Tinnitus with a normal audiogram: physiological evidence for hidden hearing loss and computational model.
Roland Schaette, David McAlpine
https://pubmed.ncbi.nlm.nih.gov/21940438Anatomical Correlates and Surgical Considerations for Localized Therapeutic Hypothermia Application in Cochlear Implantation Surgery.
Enrique Perez, Andrea Viziano, Zaid Al-Zaghal...
https://pubmed.ncbi.nlm.nih.gov/31318786Therapeutic hypothermia and targeted temperature management for traumatic brain injury: Experimental and clinical experience.
W Dalton Dietrich, Helen M Bramlett
https://pubmed.ncbi.nlm.nih.gov/30276324