External Therapy for Tinnitus Management
Restorear Devices LLC · NCT07017998
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–55 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 80
- US sites recruiting
- 1
- Study start
- July 16, 2025
- Record last updated
- July 28, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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:
- Ascertain the effects of MTH in chronic tinnitus patients using questionnaires measuring tinnitus severity and intervention-related change.
- 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.
Being studied: Cold pack-delivered mild therapeutic hypothermia; Sham (No Treatment)
Conditions: Tinnitus; Tinnitus, Subjective
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion 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).
Exclusion Criteria
- 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.
Recruiting US locations
RestorEar Devices
Bozeman, MT 59715
Site contact: Kendall Stern, MPH · (406) 414-6278 · kendall.stern@restorear.com
Study contacts (from the official record)
- Kendall Stern, MPH · 2068187219 · kendall.stern@restorear.com
- Suhrud Rajguru, PhD · (801) 641-8180 · srajguru@restorear.com