External Therapy for Tinnitus Management
Mild Therapeutic Hypothermia for Tinnitus Management
Restorear Devices LLC
80 participants
Jul 16, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria8
- 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.
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Interventions
Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound.
Sham headband-style device will be worn for 30 minutes. Participants will be told they are receiving therapy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07017998