RecruitingNot Applicable

Noninvasive Therapy for Tinnitus

United States40 participantsStarted 2025-11-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Visual Analog Scale (VAS) of Tinnitus Severity

Timeframe: VAS will be given to participants in both Experimental and Sham Arms. For Aim 1, VAS will be administered at baseline, immediately after treatment, and at 24 hours post-treatment. For Aim 2, VAS will be administered monthly for 6 months post-baseline.

Tinnitus Functional Index Adapted (TFI-Adapted)

Timeframe: TFI-Adapted will be given to participants in Aim 1. TFI-Adapted will be administered at baseline and 24 hours post-treatment.

Trial details

NCT IDNCT07071480

SponsorRestorear Devices LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Suhrud M Rajguru, PhD

801-641-8180 srajguru@restorear.com

View on ClinicalTrials.gov More Tinnitus trials