External Therapy for Tinnitus Management

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.

NCT Number	NCT07017998
Lead Sponsor	Restorear Devices LLC
Conditions	Tinnitus, Tinnitus, Subjective
Enrollment	80 participants
Start Date	2025-07-16
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-12-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-28