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Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus

NCT05441540 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-04-16

Study results available
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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.

Conditions

  • Pulsatile Tinnitus

Interventions

DEVICE

Internal Jugular Vein Compression Collar

The current FDA approved internal jugular vein compression collar, marketed as the Q collar, is manufactured by Q30 Innovations Home. It is designed to be worn around the neck of individuals aged 13 and older. It functions by lightly compressing the internal jugular vein's bilaterally, safely increasing intracranial volume and intracranial pressure. The FDA approved neck collar device is made of a thermoplastic elastomer that is specifically fitted to an individual to provide mild internal jugular vein compression. The product was developed and confirmed with ultrasonography to confirm appropriate fit and compression of the vein based on an athlete's neck circumference.

Sponsors & Collaborators

  • North Carolina Translational and Clinical Sciences Institute

    collaborator OTHER

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-27
Primary Completion
2023-07-30
Completion
2023-07-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441540 on ClinicalTrials.gov