Actively Recruiting
Noninvasive Therapy for Tinnitus
Led by Restorear Devices LLC · Updated on 2026-01-12
40
Participants Needed
1
Research Sites
79 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
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims: 1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device. 2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device. Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.
CONDITIONS
Official Title
Noninvasive Therapy for Tinnitus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of signing the consent form
- Fluency in English or Spanish
- Chronic subjective tinnitus for more than 30 days, audible at least 75% of waking hours
- At least mild tinnitus with a score of 18 or higher on the Tinnitus Handicap Inventory (THI)
You will not qualify if you...
- Severe anxiety with a score of 15 or higher on the Generalized Anxiety Disorder-7 (GAD-7) test
- Tinnitus described as non-auditory or pulsatile
- Catastrophic tinnitus with a score of 78 or higher on the THI
- Intermittent tinnitus
- Abnormal tympanometric test results
- Conductive hearing loss with air-bone gaps of 15 dB or greater at two or more consecutive frequencies
- Ear diseases including acoustic neuroma, vestibular schwannoma, chronic ear disease, Meniere's disease, fluctuating hearing loss, or ototoxicity
- Temporomandibular joint disorder
- Currently receiving medical, pharmacologic, or therapeutic treatment for tinnitus or other ear conditions
- Active use of hearing aids
- Experiencing dizziness at the time of consent or study start
- Adults unable to provide consent
- Individuals under 18 years old
- Pregnant women
- Prisoners
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
S
Suhrud M Rajguru, PhD
CONTACT
C
Curtis S King
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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