Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinn… (NCT05441540) | Clinical Trial Compass
CompletedNot Applicable
Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus
United States20 participantsStarted 2022-10-27
Plain-language summary
This study seeks to pilot an evaluation of whether an external jugular vein compression collar approved by the US Food and Drug Administration (FDA) for contact sports can provide symptomatic relief of venous pulsatile tinnitus. Furthermore, the study will evaluate quality of life impacts of the device and adherence by users.
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
* Male or female age 18 years and older
* Diagnosis of venous pulsatile tinnitus
* Patient at UNC ENT Meadowmont Clinic
Exclusion Criteria
* Increased presence of acid in the body or excessive blood alkalinity
* Open head injury (including in or around the eye) within the past six months
* Pseudotumor cerebri (false brain tumor)
* Presence of brain or spinal shunt
* Known seizure disorder
* Known airway obstruction
* Increased likelihood of blood clotting (coagulation)
* Skin injury, rash, or other abnormality on or around the neck
* age \<18
* unable to provide written consent,
* history of neurological deficits,
* previous cerebral infarction (blockage or narrowing in the arteries supplying blood and oxygen to the brain)
* severe head trauma
* medical contraindications to restriction of blood outflow via the internal jugular veins
* glaucoma (narrow angle or normal tension - increased pressure in the eyes),
* hydrocephalus (increased fluid on the brain)
* recent penetrating brain trauma (within 6 months),
* known carotid hypersensitivity
* known increased intracranial pressure
* idiopathic intracranial hypertension
* known intracranial vascular malformation (e.g. aneurysm, arteriovenous malformation, cavernoma)
* central vein thrombosis
* not tolerating initial fitting of collar.
* Known pregnancy (this is not a direct contraindication but is being made out of an abundance of caution)
* Inability to speak or comprehend English
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
1
Change From Baseline in Pulsatile Tinnitus Symptom Intensity
Timeframe: From immediately before collar placement to less than or equal to two hours of wearing the collar for each day of use.