Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory (URI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Total Symptoms Score (TSS)
研究概览
简要总结
This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 2 aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8 week fall URI season. Subjects will use an active device (positive expiratory pressure and 128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8 weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community acquired viral URIs. Subjects will use active or sham device as above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.
排除标准
- •Any transient ENT condition that may impact upper airway to include acute sinusitis or otitis.
- •Any upper respiratory illness within last 2 weeks
- •TSS will be measured at baseline as described above and must be <9 for inclusion (Eccles etal).
- •Topical decongestant use in last week
- •Current nasal crusting or history of ulceration or perforation
- •History of severe nose bleeding within last 3 months
- •Known pregnancy
- •Immunosuppressed condition or on immune modulating medications such as prednisone or chemotherapy
- •Allergic sensitivity to silicone or any other component of device
- •Inability to read and understand English
- •Inability to perform treatment due to underlying medical condition
结局指标
主要结局
Total Symptoms Score (TSS)
时间窗: 60 Days
The Total Symptom Score (TSS) was based on the severity of each of upper respiratory infection (URI) symptom. The TSS includes 9 symptoms: Lost sense of smell/taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough headache, maliase, and chilliness. The severity of URI symptoms was scored on a symptom severity scale (0 = not at all; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms) Minimum score=0; maximum score=27.
次要结局
未报告次要终点
研究者
Shaun A. Nguyen, MD
Professor
Medical University of South Carolina