| NCT ID | NCT07071480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Restorear Devices LLC |
| Condition | Tinnitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-24 |
| Primary Completion | 2026-11-30 |
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 40 participants in total. It began in 2025-11-24 with a primary completion date of 2026-11-30.
⚠ 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 interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims: 1. Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device. 2. Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device. Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or older at the time of signing the consent form * Fluency in English or Spanish * Chronic subjective tinnitus for more than 30 days defined as audible at least 75% of waking hours * At least mild tinnitus, score ≥18 on the Tinnitus Handicap Inventory (THI) Exclusion Criteria: * Severe anxiety, score ≥ 15 on the Generalized Anxiety Disorder-7 (GAD-7) * Tinnitus described as non-auditory or pulsatile in nature * Catastrophic tinnitus, score ≥78 on the THI * Tinnitus that is intermittent in nature * Abnormal tympanometric findings * Presence of conductive component as characterized by air-bone gaps ≥15 dB at two or more consecutive frequencies * Otologic pathologies (including, but not limited to): acoustic neuroma/ vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity * Temporomandibular joint disorder * Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions. * Active hearing aid use * Dizziness at the time of signing the consent form or at the time of starting the study protocol treatment * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Contact & Investigator
Suhrud M Rajguru, PhD
PRINCIPAL INVESTIGATOR
RestorEar Devices
Frequently Asked Questions
Who can join the NCT07071480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, 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 NCT07071480 currently recruiting?
Yes, NCT07071480 is actively recruiting participants. Contact the research team at keh129@med.miami.edu for enrollment information.
Where is the NCT07071480 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07071480 clinical trial?
NCT07071480 is sponsored by Restorear Devices LLC. The principal investigator is Suhrud M Rajguru, PhD at RestorEar Devices. The trial plans to enroll 40 participants.