RECRUITING

External Therapy for Tinnitus Management

Description

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 the therapy to those from a sham group (individuals receiving a sham therapy).

Conditions

TinnitusTinnitus, Subjective
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Related Conditions:

TinnitusTinnitus, Subjective

Study Overview

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Study Details

Study overview

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 the therapy to those from a sham group (individuals receiving a sham therapy).

Mild Therapeutic Hypothermia for Tinnitus Management

External Therapy for Tinnitus Management

Condition
Tinnitus
Intervention / Treatment

-

Contacts and Locations

Bozeman

RestorEar Devices, Bozeman, Montana, United States, 59715

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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).
  • * Very mild tinnitus (THI values \<12);
  • * Tinnitus that is intermittent in nature;
  • * Tinnitus described as non-auditory or pulsatile in nature;
  • * Individuals with a history of vertigo or fluctuating hearing loss, such as that related to Menière's disease, chronic otitis, vestibular neuritis, neuroma, otosclerosis cholesteatoma, or temporomandibular joint disorder;
  • * Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome.
  • * Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions, including sound therapy, cognitive behavioral therapy (CBT), Tinnitus Retraining Therapy (TRT), steroid injections, or other treatments;
  • * Those who present with a mental health score indicating significant psychological component, per standard of care, based on PHQ-4 score of moderate to severe anxiety/depression.
  • * Children (under 18 years), incarcerated individuals, adults unable to consent, and psychologically vulnerable participants.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Restorear Devices LLC,

Suhrud Rajguru, PhD, PRINCIPAL_INVESTIGATOR, RestorEar Devices

Kendall Stern, MPH, PRINCIPAL_INVESTIGATOR, RestorEar Devices

Study Record Dates

2026-12-01