NCT04191512招募中不适用
Head to Head Comparison of Upper Airway Stimulation and Continuous Positive Airway Pressure; a Pilot Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Difference in polysomnography (PSG) data between UAS and CPAP groups
研究概览
简要总结
To date, there has been no head to head comparison of Upper Airway Stimulation (UAS) and Continuous Positive Airway Pressure (CPAP) utilizing a full night polysomnographic evaluation. With this study we aim to evaluate a pilot cohort of patients with OSA treated with CPAP or UAS using the WatchPAT polysomnography system.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Age greater than 22 years old
- History of moderate to severe OSA (AHI 15-65)
- UAS implantation with postoperative titration and demonstrated successful use of therapy or has demonstrated the ability to tolerate CPAP for greater than 4 hours per night 5 days per week.
排除标准
- none
研究组 & 干预措施
Upper airway stimulation
Continuous positive airway pressure
结局指标
主要结局
Difference in polysomnography (PSG) data between UAS and CPAP groups
时间窗: 2 years
Difference in Functional Outcomes of Sleep questionnaire data between UAS and CPAP groups
时间窗: 2 years
Difference in Epworth Sleepiness Scale questionnaire data between UAS and CPAP groups
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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标识符
- NCT 编号
- NCT04191512
- 其他研究编号
- 19C.245
日期
- 首次提交
- (6年前)
- 首次发布
- (6年前)
- 主要完成日期
- (9个月后)
- 研究完成日期
- (9个月后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否
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