NCT03108417撤回不适用
Home Study of Subjects With Obstructive Sleep Apnea Who Have Previously Completed an In-Lab Continuous Negative External Pressure (cNEP) Titration and Were Considered to be "Responders"
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduction in baseline apnea hypopnea index from baseline
研究概览
简要总结
This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.
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
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have completed study SOM-012 and been categorized as a "responder"
- •the subject agrees to participation by signing an informed consent statement
排除标准
- •medical or social circumstances have changed since participation in SOM-012 such that continued use of cNEP may provide questionable benefit or associated with increased risk
研究组 & 干预措施
cNEP
Experimental
continuous negative external pressure will be used nightly by all participants
干预措施: continuous negative external pressure (Device)
结局指标
主要结局
Reduction in baseline apnea hypopnea index from baseline
时间窗: End of Week 2 of home use
Reduction in apnea hypopnea index (AHI) from the baseline value of \>50% and also \<15/hr
次要结局
- Collection of adverse events(two week study period)
- Apnea hypopnea index, as measured by home sleep testing(two weeks)
研究者
研究点 (1)
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