Noninvasive Therapy for Tinnitus
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:
| Condition(s) | Tinnitus, Tinnitus, Subjective |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 fro |
| Who can participate | 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 ea |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Restorear Devices LLC |
| Locations | Miami, Florida, United States |
| Start date | 2025-11-24 |
| NCT ID | NCT07071480 |
| Official listing | https://clinicaltrials.gov/study/NCT07071480 |