Mild Therapeutic Hypothermia for Tinnitus Management

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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).

Locations
United States
Montana
RestorEar Devices
RECRUITING
Bozeman
Contact Information
Primary
Kendall Stern, MPH
kendall.stern@restorear.com
(406) 414-6278
Backup
Suhrud Rajguru, PhD
srajguru@restorear.com
(801) 641-8180
Time Frame
Start Date: 2025-07-16
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 80
Treatments
Experimental: Experimental Arm
Participants will wear a headband-style device for 30 minutes in a single session. Subjective assessments will be completed via Qualtrics XM, and responses will be compared to those in the Sham Arm. n=40
Sham_comparator: Control Arm
Participants will wear a headband-style control device for a single 30 minute session. Subjective assessments will be completed via Qualtrics XM, and responses will be compared to those in the Experimental Arm. n=40
Related Therapeutic Areas
Sponsors
Leads: Restorear Devices LLC

This content was sourced from clinicaltrials.gov