External mild-cooling therapy for chronic tinnitus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• RestorEar Devices
  Bozeman, Montana, United States Recruiting

Study contacts

• Principal investigator: Suhrud Rajguru, PhD — RestorEar Devices
• Study coordinator: Kendall Stern, MPH
• Email: kendall.stern@restorear.com
• Phone: 2068187219

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Non-Invasive Neurofeedback for Tinnitus Distress

  This trial tests whether real-time neurofeedback training can reduce distress from tinnitus in adults with bothersome symptoms.

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• Neck nerve electrical stimulation combined with sound-frequency training for chronic tonal tinnitus

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  Recruiting University of Dublin, Trinity College · Dublin, Dublin · NCT07393880

• Noninvasive ear cooling for tinnitus

  This trial will try a noninvasive mild ear cooling device called ReBound to see if a single 30-minute session plus up to six months of home use reduces chronic subjective tinnitus in adults.

  Recruiting Restorear Devices LLC · Miami, Florida · NCT07071480

• DeepTMS for chronic tinnitus using different H-coils

  This study tests whether deep repetitive transcranial magnetic stimulation with different H-coils can reduce tinnitus distress in adults with chronic tinnitus, compared to placebo.

  Recruiting University of Regensburg · Regensburg, Bavaria · NCT07885176

• TRTL-913 in adults with tinnitus: safety and signals of benefit

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  Recruiting Phase 2 Tortugas Neuroscience, Inc. · Newcastle, New South Wales and 9 other locations · NCT07777549

• Foot reflexology or ta-VNS for tinnitus in adults

  This trial tests whether foot reflexology, left-ear vagus nerve stimulation, or auricular acupressure can help reduce tinnitus symptoms in adults with tinnitus.

  Recruiting Tzu Chi University · Hualien City · NCT07711639

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.