Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous 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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if a special collar that gently presses on a neck vein can help people with venous pulsatile tinnitus. These patients often have limited treatment options. The collar works by reducing abnormal sounds through gentle neck vein pressure.

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 data supports the effectiveness of the treatment Internal Jugular Vein Compression Collar?

Research shows that compressing the internal jugular vein can influence brain and ear pressure, and has been effective in reducing hearing damage in animal studies. However, more studies are needed to understand its long-term effects and how it might help people. ^{1 2 3 4 5}

Is the Internal Jugular Vein Compression Collar safe for use in humans?

Research indicates that cervical collars, including those that compress the jugular vein, can increase pressure in the brain and may cause skin ulcers. These effects suggest potential safety concerns, especially for head-injured patients. ^{4 6 7 8 9}

Research Team

Benjamin S Succop, B.S.

Principal Investigator

Medical Student

Brian Sindelar, MD

Principal Investigator

[e-mail]

Eligibility Criteria

Inclusion Criteria

Male or female age 18 years and older

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

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)

Treatment Details

Interventions

• Internal Jugular Vein Compression Collar

Participant Groups

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+

References

1. Turkey pubmed.ncbi.nlm.nih.gov

[Assessment of internal jugular vein flow and patency with power duplex Doppler ultrasonography after functional neck dissection]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Reduction in Temporary and Permanent Audiological Injury Through Internal Jugular Vein Compression in a Rodent Blast Injury Model. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Investigating the time-lapsed effects of rigid cervical collars on the dimensions of the internal jugular vein. [2019]

4. England pubmed.ncbi.nlm.nih.gov

The measurement of tissue interface pressures and changes in jugular venous parameters associated with cervical immobilisation devices: a systematic review. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Patency and caliber of the internal jugular vein after neck dissection. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of clinical efficacy and safety of cervical trauma collars: differences in immobilization, effect on jugular venous pressure and patient comfort. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Analysis of head impact exposure and brain microstructure response in a season-long application of a jugular vein compression collar: a prospective, neuroimaging investigation in American football. [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Cervical collars: a potential risk to the head-injured patient. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Effects of the cervical collar on cerebrospinal fluid pressure. [2022]