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

NCT05441540 | Completed Results FDA Device

• 1 other identifier: 21-3127
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 of venous pulsatile tinnitus. Furthermore, the study will evaluate quality of life impacts of the device and adherence by users.

Conditions

Pulsatile Tinnitus

Keywords

pulsatile tinnitus; Internal Jugular Vein (IJV) collar

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pulsatile Tinnitus Symptom Intensity

  Assessing the difference in pulsatile tinnitus symptom intensity without the collar vs. with the collar as evaluated by a 10 point Likert scale ranging 0-10 where 0 is no symptoms and 10 is maximal symptom intensity. Participants were allowed to use the collar for up to 30 days as often or as little as desired on a weekly basis but no longer than 2 hours continuously in accordance with the collar's FDA clearance. Participants completed a survey for each day of use reporting the intensity of their symptoms before wearing the collar and while wearing the collar. The difference between these symptom intensities with and without the collar is a single data point. Each data point was aggregated across all participants and across all days of use. From these aggregated data, the median and interquartile range were calculated. Therefore, the outcome is the median difference in intensity before and during wear of every day of collar use by every participant.

  From immediately before collar placement to less than or equal to two hours of wearing the collar for each day of use.

Secondary Outcomes (3)

• Change From Baseline in Tinnitus Quality of Life From Collar Usage

  Baseline, 5 weeks later upon completion of study participation

• Temporality of Collar Usage Effect on Symptom Intensity

  From immediately before collar placement to less than or equal to two hours of wearing the collar for each day of use.

• Observed Clinical Effect of Collar vs. Home Use Effect of Collar

  From immediately before collar placement to less than or equal to two hours of wearing the collar for each day of use.

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Device: Internal Jugular Vein Compression Collar

Interventions

Internal Jugular Vein Compression Collar DEVICE

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.

Also known as: Q collar

Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 years and older
• Diagnosis of venous pulsatile tinnitus
• Patient at UNC ENT Meadowmont Clinic

You may not qualify if:

• 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),

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

UNC Meadowmont ENT Clinic

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Benjamin Succop
• Organization: UNC School of Medicine

benjamin_succop@med.unc.edu

8284439726

Study Officials

• Benjamin S Succop, B.S.

  Medical Student

  PRINCIPAL INVESTIGATOR

• Brian Sindelar, MD

  brian_sindelar@med.unc.edu

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will be in a single treatment group

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: October 27, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: April 16, 2024
• Results First Posted: March 15, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: beginning 9 to 36 months following publication
• Access Criteria: see above

Locations

US (1)