ISRCTN04363711已完成不适用
Evaluation of fixed continuous positive airway pressure (CPAP) with C-Flex+ against fixed CPAP in patients with obstructive sleep apnoea
Philips Respironics (France)0 个研究点目标入组 85 人开始时间: 2011年1月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. AHI greater than 15 confirmed (greater than than 50% obstructive events) by full PSG within last 14 days
- •2. Age greater than or equal to 21 years of age
- •3. Able to provide consent
- •4. Able to follow the instructions given by the investigator regarding using their CPAP device and their participation in this study
排除标准
- •1. Inability to tolerate CPAP during the daytime CPAP session
- •2. Failure of CPAP to adequately treat OSA during titration (AHI greater than or equal to 15.0/h under the determined optimal pressure)
- •3. PAP therapy is otherwise medically contraindicated: acute upper respiratory infection, encephalitis, sinusitis or middle ear infection or surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- •4. Untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic leg movements (PLM)/restless legs syndrome (RLS)
- •5. Treated insomnia
- •6. Intake of central relevant drugs, sedatives, or other drugs which impair sleep
- •7. Previous exposure to positive airways pressure therapy
- •8. Acute dermatitis or other skin lesions or trauma interfering with the application of a mask
- •9. Unwilling to participate in the study
- •10. Participation in another clinical study in the past 4 weeks
- •11. Shift worker
研究者
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