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Noninvasive Therapy for Tinnitus
Sponsor: 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.
Official title: Noninvasive Therapeutic Hypothermia for Tinnitus
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-11-24
Completion Date
2027-05-31
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
Cold 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.
Sham 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.
Locations (1)
University of Miami
Miami, Florida, United States