Therapeutic Hypothermia for Tinnitus

Overseen By Kendall Stern, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Restorear Devices LLC

Disqualifiers: Vertigo, Menière's, Otitis, Raynaud's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Suhrud Rajguru, PhD

Principal Investigator

RestorEar Devices

Kendall Stern, MPH

Principal Investigator

RestorEar Devices

Are You a Good Fit for This Trial?

This trial is for individuals with chronic tinnitus, which means they experience persistent ringing in their ears. Participants will be asked to use a hypothermia therapy device for a single session and complete questionnaires about their tinnitus severity.

Inclusion Criteria

I am between 18 and 55 years old and have tinnitus.

I have been experiencing ringing in my ears for over a month.

My tinnitus is severe, with a THI score of 12 or more.

Exclusion Criteria

I have a history of ear or balance issues due to specific conditions.

Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome

I experience a pulsing sound in my ears that's not caused by external noise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear the mild therapeutic hypothermia therapy devices for a single 30-minute session

1 day

1 session (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 hours

What Are the Treatments Tested in This Trial?

Interventions

• Cold pack-delivered mild therapeutic hypothermia

Trial Overview The study is testing the effectiveness of cold pack-delivered mild therapeutic hypothermia (MTH) against no treatment (sham) in reducing symptoms of chronic tinnitus. The comfort and acceptability of the device are also being evaluated.

How Is the Trial Designed?

Group I: Experimental Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Restorear Devices LLC

Lead Sponsor

Trials

2

Recruited

170+