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RECRUITING
NCT07017998
NA

External Therapy for Tinnitus Management

Sponsor: Restorear Devices LLC

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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