External mild-cooling therapy for chronic tinnitus

Mild Therapeutic Hypothermia for Tinnitus Management

This test will see if wearing a mild external cooling device for 30 minutes can reduce symptoms in adults 18–55 with constant subjective tinnitus.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Restorear Devices LLC (Industry-sponsored)
• Locations: 1 site (Bozeman, Montana)
• Trial ID: NCT07017998 on ClinicalTrials.gov

What this trial studies

This remote interventional study enrolls adults aged 18–55 with constant subjective tinnitus and a Tinnitus Handicap Inventory (THI) score of 12 or higher. Participants will use a mild therapeutic hypothermia device applied externally for a single 30-minute session or be assigned to a sham/no-treatment control group. Researchers will compare pre- and post-treatment questionnaire measures of tinnitus severity and collect data on device comfort and acceptability. The primary focus is on short-term symptomatic change and tolerability rather than long-term outcomes.

Who should consider this trial

Good fit: Adults 18–55 with constant subjective tinnitus for at least 30 days and THI scores ≥12 who are not receiving concurrent active tinnitus treatments are the intended participants.

Not a fit: People with very mild or intermittent tinnitus, pulsatile or non-auditory tinnitus, histories of vertigo or fluctuating hearing loss, extreme cold sensitivity (e.g., Raynaud's), or those on other active tinnitus therapies are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, the device could offer a simple, noninvasive option for short-term relief of tinnitus symptoms for some patients.

How similar studies have performed: Cooling-based approaches for tinnitus are largely novel with limited prior clinical evidence, so this approach remains experimental.

Eligibility 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.

Where this trial is running

Bozeman, Montana

• RestorEar Devices — Bozeman, Montana, United States (Recruiting)

Study contacts

• Principal investigator: Suhrud Rajguru, PhD — RestorEar Devices
• Study coordinator: Kendall Stern, MPH

Conditions Tinnitus; Tinnitus, Subjective; tinnitus; ringing in the ears; ringing ears; symptom management; cooling; red light therapy