ISRCTN56755910进行中（未招募）未知
Observational study investigating the long term safety and efficacy of the sleep position trainer in patients with positional obstructive sleep apnea
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- Philips
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Adult patients with a diagnosis of supine-dependent OSA defined as;
- •1.1. an AHI supine = 2x AHI non supine, or,
- •1.2. AHI non-supine < 10/h and an AHI supine = 10/h,
- •1.3. and 10 – 90 % supine sleep during PSG.
排除标准
- •1. A female of child-bearing potential that is pregnant or intends to become pregnant.
- •2. Any unstable or severe medical condition of any organ system that at the discretion of the site Principal Investigator (PI) might affect the patient’s participation in the study or generalization of treatment results.
- •3. Taking medication that at the discretion of the site Principal Investigator (PI) might affect the patient’s participation in the study or generalization of treatment results.
- •4. Oxygen use
- •5. The presence of any other sleep disorder (central sleep apnea (CSA >5), periodic limb movement disorder (PLMAI >15), clinical diagnosis of insomnia or narcolepsy)
- •6. Excessive alcohol consumption (>21 drinks/week)
- •7. The use of any illegal drug(s), per subject report.
- •8. Night or rotating shift work.
- •9. Severe claustrophobia.
- •10. Shoulder, neck, or back complaints that restrict sleeping position.
- •11. Subject requires use of more than 2 pillows under the head while sleeping or sleeps in a bed/chair with raised upper body position.
- •12. Driving risk: any car accident or near miss accident caused by sleepiness in the last 12 months and upon PI discretion
研究者
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