RecruitingNot ApplicableNCT07017998

External Therapy for Tinnitus Management

Mild Therapeutic Hypothermia for Tinnitus Management


Sponsor

Restorear Devices LLC

Enrollment

80 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Cold pack-delivered mild therapeutic hypothermia and a medical device called Sham (No Treatment) for people with tinnitus and tinnitus, subjective. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICECold 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.

DEVICESham (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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07017998


Related Trials