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External Therapy for Tinnitus Management
Sponsor: 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.
Official title: Mild Therapeutic Hypothermia for Tinnitus Management
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-07-16
Completion Date
2026-12-01
Last Updated
2025-09-17
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 (No Treatment)
Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.
Locations (1)
RestorEar Devices
Bozeman, Montana, United States