N/A
N=20
Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus
Pulsatile Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT05441540 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change From Baseline in Pulsatile Tinnitus Symptom Intensity — 3 units on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internal Jugular Vein Compression Collar (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pulsatile Tinnitus Symptom Intensity |
3 | <0.0001 sig |
| SECONDARY Change From Baseline in Tinnitus Quality of Life From Collar Usage |
12 | <0.0001 sig |
| SECONDARY Temporality of Collar Usage Effect on Symptom Intensity |
2; 2; 2; 3 | 0.7613 |
| SECONDARY Observed Clinical Effect of Collar vs. Home Use Effect of Collar |
2; 3 | 0.7640 |
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.
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
Data sourced from ClinicalTrials.gov (NCT05441540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.