Pulsatile Tinnitus
Conditions
Keywords
pulsatile tinnitus, Internal Jugular Vein (IJV) collar
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.
Detailed description
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.
Interventions
DEVICEInternal 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
North Carolina Translational and Clinical Sciences Institute
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants will be in a single treatment group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female age 18 years and older * Diagnosis of venous pulsatile tinnitus * Patient at UNC ENT Meadowmont Clinic
Exclusion criteria
* 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), * hydrocephalus (increased fluid on the brain) * recent penetrating brain trauma (within 6 months), * known carotid hypersensitivity * known increased intracranial pressure * idiopathic intracranial hypertension * known intracranial vascular malformation (e.g. aneurysm, arteriovenous malformation, cavernoma) * central vein thrombosis * not tolerating initial fitting of collar. * Known pregnancy (this is not a direct contraindication but is being made out of an abundance of caution) * Inability to speak or comprehend English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pulsatile Tinnitus Symptom Intensity | From immediately before collar placement to less than or equal to two hours of wearing the collar for each day of use. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tinnitus Quality of Life From Collar Usage | Baseline, 5 weeks later upon completion of study participation | 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. |
| 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. | 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. |
| 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group Device will be fitted and worn up to two hours daily and participants will log changes in symptom intensity before and during device usage
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. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 10 |
| Body Mass Index (BMI) | 26 kg/m^2 STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other Race | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 15 Participants |
| Region of Enrollment United States | 18 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Group | Change From Baseline in Pulsatile Tinnitus Symptom Intensity | 3 units on a scale |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Treatment Group | Change From Baseline in Tinnitus Quality of Life From Collar Usage | 12 score on a scale |
p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Observed Clinical Effect of Collar vs. Home Use Effect of Collar | Clinic Measurement | 2 units on a scale |
| Treatment Group | Observed Clinical Effect of Collar vs. Home Use Effect of Collar | Home Measurement | 3 units on a scale |
p-value: 0.764Wilcoxon (Mann-Whitney)
Secondary
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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Treatment Group | Temporality of Collar Usage Effect on Symptom Intensity | Week 2 | 2 units on a scale |
| Treatment Group | Temporality of Collar Usage Effect on Symptom Intensity | Week 1 | 2 units on a scale |
| Treatment Group | Temporality of Collar Usage Effect on Symptom Intensity | Week 3 | 2 units on a scale |
| Treatment Group | Temporality of Collar Usage Effect on Symptom Intensity | Week 4 | 3 units on a scale |
p-value: 0.7613Kruskal-Wallis