Noninvasive Therapeutic Hypothermia for Tinnitus
Restorear Devices LLC
Summary
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.
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 \[1\] 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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Abnormal tympanometric findings * Presence of condu…
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 device
Sham headband-style device. Participants assigned to use this device will be told they are receiving therapy for 30 minutes. However, no therapy is being provided.
Location
- University of MiamiMiami, Florida