Clinical trial NCT05441540: Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus
Official title: Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulsatile Tinnitus
Keywords: pulsatile tinnitus
Internal Jugular Vein (IJV) collar
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: North Carolina Translational and Clinical Sciences Institute
First posted: 2022-07-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will be in a single treatment group
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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 Ear Nose and Throat (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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Change From Baseline in Tinnitus Quality of Life From Collar Usage
timeFrame: Baseline, 5 weeks later upon completion of study participation
measure: Temporality of Collar Usage Effect on 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.
measure: Observed Clinical Effect of Collar vs. Home Use Effect of Collar
timeFrame: From immediately before collar placement to less than or equal to two hours of wearing the collar for each day of use.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Meadowmont ENT Clinic
state: North Carolina
Study officials:
affiliation: Medical Student
name: Benjamin S Succop, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: brian_sindelar@med.unc.edu
name: Brian Sindelar, MD
role: STUDY_DIRECTOR
References: