Internal Jugular Vein Compression Collar for Novel Symptomatic Treatment of Venous Pulsatile Tinnitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change From Baseline in Pulsatile Tinnitus Symptom Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change From Baseline in Pulsatile Tinnitus Symptom Intensity
时间窗: 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.
次要结局
- 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.)
- Change From Baseline in Tinnitus Quality of Life From Collar Usage(Baseline, 5 weeks later upon completion of study participation)
