Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus

Study Overview
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Brief Summary
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This study seeks to pilot an evaluation of whether an external jugular vein compression collar approved by the 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.

Detailed Description
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Background: Tinnitus is a medical condition with a wide variety of causes that is characterized by the perception of sound, often described as ringing or buzzing, without an external stimulus. Venous pulsatile tinnitus is a specific subtype of tinnitus with limited treatment options: some cases can be treated with surgical correction of an underlying vascular defect, others are entirely idiopathic. The clinical diagnostic hallmark of venous pulsatile tinnitus is relief of symptoms with light compression of the ipsilateral external jugular vein by the physician. Internal jugular vein compression collars, FDA approved devices currently used to prevent brain injuries in contact sports, function by this exact same method. Therefore, it is believed that these collars can treat pulsatile tinnitus. Study Design: This is a non-blinded, interventional, prospective single cohort pilot study that will recruit 20 patients diagnosed with pulsatile tinnitus at the UNC Meadowmont ENT clinic (see methods for inclusion/exclusion criteria). Volunteers will compare tinnitus intensity before and after administration of the collar, take the collar home and evaluate its symptomatic efficacy over a 2-4-week period, and return to clinic to complete data on quality of life and longitudinal impacts. This data will be analyzed for significance. Expected Outcomes: It is expected that collar administration will offer immediate symptomatic relief, illustrated as significant improvement on the tinnitus intensity scale during their initial clinic visit Symptomatic improvement will be sustained while wearing the collar, measured by sustained improvement in the tinnitus handicap inventory over the course of the study. Lastly, the collar will improve quality of life as measured by patient reported outcome scales administered pre and post participation.

Official Title
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Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus

Conditions
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Pulsatile Tinnitus

Intervention / Treatment
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* Device: Internal Jugular Vein Compression Collar


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All participants will be in a single treatment group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Device will be fitted and worn up to two hours daily and participants will log changes in symptom intensity before and during device usage | Device: Internal Jugular Vein Compression Collar<br>* The current FDA approved internal jugular vein compression collar, marketed as the Q collar, is manufactured by Q30 Innovations Home. It is designed to be worn around the neck of individuals aged 13 and older. It functions by lightly compressing the internal jugular vein's bilaterally, safely increasing intracranial volume and intracranial pressure. The FDA approved neck collar device is made of a thermoplastic elastomer that is specifically fitted to an individual to provide mild internal jugular vein compression. The product was developed and confirmed with ultrasonography to confirm appropriate fit and compression of the vein based on an athlete's neck circumference.<br>* Other names: Q collar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collar Effect on Symptom Intensity | Assessing the difference in pulsatile tinnitus symptom intensity without the collar vs. with the collar as evaluated by a 10 point Likert scale ranging 0-10 where 0 is no symptoms and 10 is maximal symptom intensity. | Up to 2 hours of collar usage on a daily basis for two to four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinnitus Quality of Life impact of collar usage | Determine if quality of life changes appreciably while using the collar and participating in the study as measured by the tinnitus handicap inventory (THI), a 25-item validated survey that evaluates the degree of impact a patient's tinnitus has on their quality of life. It is scored on a scale of 0-100, where 0 represents no handicap and 100 represent catastrophic handicap. | Entire 2 to 4 week course of participation | 
| Temporality of Collar Usage Effect on Symptom Intensity | Tinnitus intensity scale submissions will be plotted and compared over time course of study to determine if the effect of the collar on symptom intensity changes with time | Entire 2 to 4 week course of participation | 
| Observed clinical effect of collar vs. home use effect of collar | Supervised tinnitus intensity scale measurements will be compared to at home measurements to evaluate if perception of symptomatic intensity varies with clinical vs. at home environment when using device | Entire 2 to 4 week course of participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulsatile tinnitus, Internal Jugular Vein (IJV) collar