Trial Outcomes & Findings for Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus (NCT NCT05441540)

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

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.

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.

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.

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.