Status:
COMPLETED
Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
North Carolina Translational and Clinical Sciences Institute
Conditions:
Pulsatile Tinnitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05441540
Start Date
October 27 2022
End Date
July 30 2023
Last Update
April 16 2024
Active Locations (1)
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1
UNC Meadowmont ENT Clinic
Chapel Hill, North Carolina, United States, 27517