Noninvasive Therapy for Tinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRestorear Devices LLC
About this trial
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.
Eligibility criteria
Qualifiers
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 defined as audible at least 75% of waking hours
At least mild tinnitus, score ≥18 on the Tinnitus Handicap Inventory (THI)
Disqualifiers
Severe anxiety, score ≥ 15 on the Generalized Anxiety Disorder-7 (GAD-7)
Tinnitus described as non-auditory or pulsatile in nature
Catastrophic tinnitus, score ≥78 on the THI
Tinnitus that is intermittent in nature
Trial design
Treatments tested in this trial
- Cold pack-delivered mild therapeutic hypothermia
- Sham device
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Restorear Devices LLC
Lead sponsor
University of Miami
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator
Source ClinicalTrials.gov