Mild Therapeutic Hypothermia for Tinnitus Management
Restorear Devices LLC
Summary
The goal of this remote interventional clinical study is to investigate the use of mild therapeutic hypothermia devices for the symptomatic relief of chronic tinnitus. The main aims of the study are: 1. Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change. 2. Ascertain the comfort and acceptability of the hypothermia device and therapy. Participants with chronic tinnitus will wear the mild therapeutic hypothermia therapy devices for a single 30 minute session. Researchers will compare results from those receiving therapy to those from a control group.
Description
Tinnitus is the perception of sound in the absence of an external stimulus, commonly described as ringing in the ears. Tinnitus is a highly common condition, with most individuals experiencing it at some point in their lifetime. At least 1 in 10 US adults experience chronic or disabling tinnitus, with a significant negative impact on quality of life, often affecting sleep, concentration, mood, and hearing ability. Tinnitus can be intermittent or constant in nature, and intensity can vary or be exacerbated by stress, noise exposure, or other factors. Currently, there is no widely applicable cur…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adults 18-55 years of age at the time of signing the informed consent form with primary complaint of tinnitus; * Suffering from subjective tinnitus for at least 30 days; * Tinnitus whose level of severity is defined by Tinnitus Handicap Inventory (THI) values ≥12, * Tinnitus is constant in nature (defined as audible at least 75% of waking hours). Exclusion Criteria: * Very mild tinnitus (THI values \<12); * Tinnitus that is intermittent in nature; * Tinnitus described as non-auditory or pulsatile in nature; * Individuals with a history of vertigo or fluctuating hearing…
Interventions
- DeviceCold 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, ReBound.
- DeviceSham (No Treatment)
Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.
Location
- RestorEar DevicesBozeman, Montana