An interventional study of Internal Jugular Vein Compression Collar in Pulsatile Tinnitus, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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.
Background: Tinnitus is a medical condition with a wide variety of causes that is characterized by the perception of sound, often described as ringing or buzzing, without an external stimulus. Venous pulsatile tinnitus is a specific subtype of tinnitus with limited treatment options: some cases can be treated with surgical correction of an underlying vascular defect, others are entirely idiopathic. The clinical diagnostic hallmark of venous pulsatile tinnitus is relief of symptoms with light compression of the ipsilateral external jugular vein by the physician. Internal jugular vein compression collars, FDA approved devices currently used to prevent brain injuries in contact sports, function by this exact same method. Therefore, it is believed that these collars can treat pulsatile tinnitus.
Study Design:
This is a non-blinded, interventional, prospective single cohort pilot study that will recruit 20 patients diagnosed with pulsatile tinnitus at the UNC Meadowmont Ear Nose and Throat (ENT) clinic (see methods for inclusion/exclusion criteria). Volunteers will compare tinnitus intensity before and after administration of the collar, take the collar home and evaluate its symptomatic efficacy over a 2-4-week period, and return to clinic to complete data on quality of life and longitudinal impacts. This data will be analyzed for significance.
Expected Outcomes:
It is expected that collar administration will offer immediate symptomatic relief, illustrated as significant improvement on the tinnitus intensity scale during their initial clinic visit Symptomatic improvement will be sustained while wearing the collar, measured by sustained improvement in the tinnitus handicap inventory over the course of the study. Lastly, the collar will improve quality of life as measured by patient reported outcome scales administered pre and post participation.
412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 339 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
Of its 155 completed or terminated interventional studies of FDA-regulated products, 136 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
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
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
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.
Time frame: From immediately before collar placement to less than or equal to two hours of wearing the collar for each day of use.
Change From Baseline in Tinnitus Quality of Life From Collar Usage
Determine if quality of life changes appreciably while using the collar and participating in the study as measured by the tinnitus handicap inventory (THI), a 25-item validated survey that evaluates the degree of impact a patient's tinnitus has on their quality of life. It is scored on a scale of 0-100, where 0 represents no handicap and 100 represent catastrophic handicap.
Time frame: Baseline, 5 weeks later upon completion of study participation
Temporality of Collar Usage Effect on 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 containing a 0-10 point Likert scale of tinnitus intensity (where 0 is no symptoms and 10 is maximal symptom intensity) 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. These data points were grouped by week (week 1, week 2, week 3, week 4) across participants and the median for each reported. These medians were compared statistically to determine if the effect of the collar on symptom intensity changed by week.
Time frame: 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
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 of these data points were grouped by location of measurement (in clinic vs. at-home) across participants, the medians of each of these two groups were reported, and then statistically compared to evaluate if the change in symptom intensity varied by location of measurement.
Time frame: From immediately before collar placement to less than or equal to two hours of wearing the collar for each day of use.
| Milestone | Treatment Group |
|---|---|
| Started | 20 |
| Completed | 18 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| units on a scale | Treatment Group |
|---|---|
| Change From Baseline in Pulsatile Tinnitus Symptom Intensity | 3 (1 to 4) |
Determine if quality of life changes appreciably while using the collar and participating in the study as measured by the tinnitus handicap inventory (THI), a 25-item validated survey that evaluates the degree of impact a patient's tinnitus has on their quality of life. It is scored on a scale of 0-100, where 0 represents no handicap and 100 represent catastrophic handicap.
| score on a scale | Treatment Group |
|---|---|
| Change From Baseline in Tinnitus Quality of Life From Collar Usage | 12 (7 to 16) |
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 containing a 0-10 point Likert scale of tinnitus intensity (where 0 is no symptoms and 10 is maximal symptom intensity) 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. These data points were grouped by week (week 1, week 2, week 3, week 4) across participants and the median for each reported. These medians were compared statistically to determine if the effect of the collar on symptom intensity changed by week.
| units on a scale | Treatment Group |
|---|---|
| Week 1 | 2 (1.00 to 3.00) |
| Week 2 | 2 (2.00 to 3.00) |
| Week 3 | 2 (1.00 to 3.00) |
| Week 4 | 3 (1.25 to 3.00) |
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 of these data points were grouped by location of measurement (in clinic vs. at-home) across participants, the medians of each of these two groups were reported, and then statistically compared to evaluate if the change in symptom intensity varied by location of measurement.
| units on a scale | Treatment Group |
|---|---|
| Clinic Measurement | 2 (1.00 to 3.00) |
| Home Measurement | 3 (2.00 to 3.00) |
Collected over From the time of signing informed consent through the study debrief visit, a total of about 5 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Treatment Group |
|---|---|
| Mean | 45 ± 10 |
| Sex: Female, Male(Participants) | Treatment Group |
|---|---|
| Female | 12 |
| Male | 6 |
| Race/Ethnicity, Customized(Participants) | Treatment Group |
|---|---|
| Race/Ethnicity — White | 15 |
| Race/Ethnicity — Black/African American | 2 |
| Race/Ethnicity — Other Race | 1 |
| Region of Enrollment(Participants) | Treatment Group |
|---|---|
| United States | 18 |
| Body Mass Index (BMI)(kg/m^2) | Treatment Group |
|---|---|
| Mean | 26 ± 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Supporting information: Study protocol, Sap
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of North Carolina, Chapel Hill