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NCT07017998
External Therapy for Tinnitus Management
Conditions: Tinnitus, Tinnitus, Subjective
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Restorear Devices LLC
Location: RestorEar Devices Bozeman Montana
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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07017998). StuddyBuddy aggregates publicly available trial information.