Mild Therapeutic Hypothermia for Tinnitus Management

What this Trial Is About

This research aims to evaluate the use of mild therapeutic hypothermia (MTH) devices to relieve symptoms in adults with chronic tinnitus, a common condition characterized by hearing ringing or other sounds without an external source. Tinnitus often affects quality of life by impacting sleep, concentration, mood, and hearing. Current treatments usually focus on managing symptoms rather than addressing the root cause, and this study investigates MTH as a novel, non-invasive approach for tinnitus management. Participants will be randomly assigned to wear a specially designed headband-style device called ReBound that delivers cooling therapy to the inner ear for 30 minutes at home, or a sham device that looks the same but does not provide active therapy. The study compares changes in tinnitus severity immediately before and after treatment by using questionnaires. Comfort and acceptability of the device will also be assessed through a brief questionnaire after treatment. Throughout the study, participants will complete subjective assessments online before and after the single treatment session, including tinnitus severity scales and device acceptance questions. Researchers will monitor for any side effects or adverse events related to the therapy. The main outcome measured is the change in tinnitus severity immediately before and after treatment, with additional evaluations of symptom improvement, device comfort, and any adverse events. The study is conducted fully remotely, allowing participants to engage from their homes.

External Therapy for Tinnitus Management