Noninvasive Therapeutic Hypothermia for Tinnitus

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims: 1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device. 2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device. Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adults aged 18 years or older at the time of signing the consent form

• Fluency in English or Spanish

• Chronic subjective tinnitus for more than 30 days defined as audible at least 75% of waking hours

• At least mild tinnitus, score ≥18 on the Tinnitus Handicap Inventory (THI)

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Suhrud M Rajguru, PhD
srajguru@restorear.com
801-641-8180
Backup
Curtis S King
cking@restorear.com
406-414-6278
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 40
Treatments
Experimental: Mild Therapeutic Hypothermia (MTH) Arm
Subjects will receive hypothermia treatment delivered with ReBound devices, applied in a single 30 minute session in-clinic. Baseline audiometric testing and subjective tinnitus assessment will be measured prior to initiation of the treatment. Testing will be repeated immediately after treatment, and changes will be noted. Subjects in this group will also be sent home with a device to use as needed for a period of 6 months. They will be asked to complete monthly subjective surveys online assessing tinnitus severity and monitoring potential adverse events. MTH Arm will complete both Aims 1 and 2. n=20.
Sham_comparator: Control Arm
Subjects will receive a sham wearable headband in a single 30 minute session in-clinic. Baseline audiometric testing and subjective tinnitus assessment will be measured prior to initiation of the treatment. Testing will be repeated immediately after treatment, and changes will be noted. Subjects in this group will also be sent home with a device to use as needed for a period of 6 months. They will be asked to complete monthly subjective surveys online assessing tinnitus severity and monitoring potential adverse events. Control Arm will complete both Aims 1 and 2. n=20.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD), University of Miami
Leads: Restorear Devices LLC

This content was sourced from clinicaltrials.gov