NCT07017998 External Therapy for Tinnitus Management
| NCT ID | NCT07017998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Restorear Devices LLC |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2025-07-16 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Suhrud Rajguru, PhD
PRINCIPAL INVESTIGATOR
RestorEar Devices
Frequently Asked Questions
Who can join the NCT07017998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Tinnitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07017998 currently recruiting?
Yes, NCT07017998 is actively recruiting participants. Contact the research team at kendall.stern@restorear.com for enrollment information.
Where is the NCT07017998 trial being conducted?
This trial is being conducted at Bozeman, United States.
Who is sponsoring the NCT07017998 clinical trial?
NCT07017998 is sponsored by Restorear Devices LLC. The principal investigator is Suhrud Rajguru, PhD at RestorEar Devices. The trial plans to enroll 80 participants.