NCT02677168已完成不适用
Continuous Negative External Pressure (cNEP) for the Treatment of Obstructive Sleep Apnea (OSA)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- "Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
研究概览
简要总结
The purpose of this study is to determine whether cNEP (continuous positive external pressure) is effective in treating obstructive sleep apnea
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
- 否
入选标准
- •PSG performed within the previous twelve months that documents the presence of obstructive sleep apnea (the "qualifying PSG")
- •on that PSG, AHI must be 10 - 50/hr and >80% of the apneas and hypopneas must be obstructive
- •no significant changes in health, medications, or lifestyle since the qualifying PSG
排除标准
- •previous major surgery, injury or radiation to the neck
- •beard or excessive hair on the area of the neck where the collar will be applied
- •carotid artery disease
- •serious medical conditions
- •pregnancy
- •use of home oxygen
- •silicone allergy
- •sleep disturbance other than obstructive sleep apnea
研究组 & 干预措施
cNEP
Experimental
Subjects with OSA will be treated with cNEP (continuous negative external pressure) at home for three weeks
干预措施: cNEP (Device)
结局指标
主要结局
"Sustained Response" of reduction of AHI (apnea hypopnea index) at PSG (polysomnography) II
时间窗: three weeks--PSG II will be done after three weeks of home use of cNEP following PSG I
A response (either initial or sustained) is defined as an AHI that is \< 50% of the qualifying PSG (polysomnography) that is also \< 15/hr
occurrence of adverse events
时间窗: three weeks
Adverse events that occur during the three weeks of cNEP home use.
次要结局
- time of SpO2 (oxygen saturation) < 90%(during each of the overnight PSGs)
- Three CGI (clinical global impression) subjective measures(three weeks after the initiation of home cNEP)
- "Initial Response" of AHI at PSG I(up to 12 months after the qualifying PSG)
- Comparison of AHI at PSG I and PSG II(three weeks)
- hours of home use of cNEP per night(three weeks after initiation of home cNEP)
研究者
研究点 (2)
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