BridgeMD
New treatment option for Tinnitus
Official title External Therapy for Tinnitus Management
ClinicalTrials.gov ID: NCT07017998
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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).
You likely can't join if
- 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...
- 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...
See the full eligibility 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bozeman, Montana, 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 to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bozeman, Montana, 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.