NCT00849043已完成不适用
A Single Arm, Open-label Extension Study to Evaluate the Long-term Durability of Treatment Response and and Safety of the Provent Professional Sleep Apnea Therapy Device for the Non-invasive Treatment of Obstructive Sleep Apnea-hypopnea
Ventus Medical, Inc.13 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2009年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 13
- 主要终点
- To measure the percent change in the subject's apnea-hypopnea index (AHI) during the 12 month PSG while wearing the Provent device as compared to their AHI during the first week PSG when the subject did not wear the Provent device in the C009 study
研究概览
简要总结
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea (OSAH), and were actively using the Provent device.
研究设计
- 研究类型
- Observational
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
- •Based upon scoring at the study site, the 3-month 'device on' PSG has a 50% reduction in AHI compared to the 1-week 'device off' PSG AHI OR the 3-month 'device on' PSG AHI <10
- •Used the Provent device at least 4 hours for at least 5/7 nights per week on average during months 1 and 2 of the three month C009 study
- •The study physician and investigator believe that continued Provent use does not represent a significant safety risk for the patient
- •Patient understands and is willing and able to comply with study requirements
排除标准
- •The patient must continue to not meet all of the exclusion criteria of protocol C009
结局指标
主要结局
To measure the percent change in the subject's apnea-hypopnea index (AHI) during the 12 month PSG while wearing the Provent device as compared to their AHI during the first week PSG when the subject did not wear the Provent device in the C009 study
时间窗: 12 months
次要结局
- Measurement of the subjects quality of life(12 months)
研究者
研究点 (13)
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