Compression Collar for Pulsatile Tinnitus

Overseen By Brian Sindelar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Seizure disorder, Glaucoma, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a special neck collar, originally used in contact sports, can help people with venous pulsatile tinnitus, a condition characterized by a rhythmic noise in the ear. Researchers aim to determine if daily use of this collar reduces the noise and improves quality of life. Patients diagnosed with venous pulsatile tinnitus at the UNC ENT Meadowmont Clinic may qualify for this study. As an unphased trial, this study provides a unique opportunity to explore an innovative treatment that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this external jugular vein compression collar is safe for use in treating venous pulsatile tinnitus?

Research has shown that the internal jugular vein compression collar is safe to use. The FDA has approved this device for preventing brain injuries in sports. It functions by gently pressing on the veins in the neck, which can help protect the brain during impacts.

Results from 17 studies suggest that people tolerate the collar well and that it helps protect the brain. These studies have reported no major safety issues. While the current study examines the collar's use in treating venous pulsatile tinnitus (a type of ringing in the ears), its safety record in sports is promising. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Internal Jugular Vein Compression Collar because it offers a novel approach to managing venous pulsatile tinnitus. Unlike traditional treatments, which might involve medication or surgery to alleviate symptoms, this collar provides a non-invasive, mechanical method to potentially reduce tinnitus by applying gentle compression to the internal jugular vein. This could offer a safer, more convenient option for patients, as it doesn’t involve the side effects or recovery time associated with more invasive procedures. Additionally, the ability to adjust usage based on symptom intensity allows for personalized treatment, which could lead to better patient outcomes.

What evidence suggests that this external jugular vein compression collar is effective for venous pulsatile tinnitus?

Research shows that a special collar, often used in contact sports, might help with venous pulsatile tinnitus, a type of ear noise. This trial will evaluate the Internal Jugular Vein Compression Collar, which gently presses on neck veins to potentially control blood flow and reduce noise. Studies have found that this collar protects the brain from impacts, suggesting it might also alleviate ear symptoms. Although the FDA has approved the collar for sports, its use for tinnitus remains under study in this trial, with hopes for positive results in reducing symptoms. ^{1 2 3 6 7}

Who Is on the Research Team?

Benjamin S Succop, B.S.

Principal Investigator

Medical Student

Brian Sindelar, MD

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

Inclusion Criteria

Patient at UNC ENT Meadowmont Clinic

You have been diagnosed with a specific type of ringing in your ears caused by problems with your veins.

Exclusion Criteria

Unable to provide written consent

Age less than 18

Increased likelihood of blood clotting (coagulation)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the internal jugular vein compression collar for up to 30 days, logging changes in symptom intensity

4 weeks

1 initial visit (in-person), daily self-reports

Follow-up

Participants are monitored for changes in quality of life and symptom intensity after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Internal Jugular Vein Compression Collar

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Device will be fitted and worn up to two hours daily and participants will log changes in symptom intensity before and during device usage

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

North Carolina Translational and Clinical Sciences Institute

Collaborator

Trials

61

Recruited

4,600+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11743508/

A Narrative Review of the Effects of Internal Jugular Vein ...

Our review of the 17 studies shows an overall neuroprotective effect of the external jugular vein compression applied by the cervical collar ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7222254/

THE EFFECTS OF INTERNAL JUGULAR VEIN ...

The present results provide support for internal jugular vein compression to protect the brain from both low- and high-level repeated head impact exposure.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05441540?term=AREA%5BConditionSearch%5D(pulsatile)&rank=3

Internal Jugular Vein Compression Collar for Novel ...

This data will be analyzed for significance. Expected Outcomes: It is expected that collar administration will offer immediate symptomatic relief, illustrated ...

4.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN200017.pdf

den200017 decision summary - accessdata.fda.gov

The Q-Collar has not been demonstrated to prevent long-term cognitive function deficits, and the ultimate impact on clinical outcomes has not been evaluated ...

5.

q30.com

q30.com/pages/fda-reviewed?srsltid=AfmBOorz9SVd_DXDrpDkfEvPcifsZW9_98uFU3OaeAEDDCv2vb0nTgZq

FDA-Cleared Q-Collar: Research Brief

These studies indicate that compression of the internal jugular veins (IJVs) reduces the risk and severity of brain injury during impact and blast events.

6.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/40/NCT05441540/Prot_SAP_001.pdf

Internal Jugular Vein Compression Collar for Novel

The purpose of the study is to determine the preliminary efficacy of an internal jugular vein compression collar for treating pulsatile tinnitus ...

7.

q30.com

q30.com/pages/fda-reviewed?srsltid=AfmBOoqkWr0TNxHt5OXtOwhqxmrpEuk4ISNr4DlFM214Qvne2sKeqg8H

FDA-Cleared Q-Collar: Research Brief

These studies indicate that compression of the internal jugular veins (IJVs) reduces the risk and severity of brain injury during impact and blast events.