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New treatment option for Tinnitus
Official title Noninvasive Therapy for Tinnitus
ClinicalTrials.gov ID: NCT07071480
What this study is testing
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.