ISRCTN39453867已完成不适用
Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ResMed
- 入组人数
- 228
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. Newly-diagnosed Obstructive Sleep Apnoea / Hypopnoea Syndrome (OSAHS) patients
- •2. Daytime sleepiness and =3 of listed symptoms (snoring, morning headaches, reduced alertness, libido disorders, hypertension or nocturia) associated with an apnea-hypopnea index (AHI) of >30/h or 5-30/h with =10 respiratory event-related arousals with an increase in respiratory effort documented by polysomnography (PSG),
- •3. Central apnea index of =20%,
- •4. Absence of nocturnal mouth leaks detected during CPAP treatment initiation,
- •5. No known allergy to silicone,
- •6. Fitted with an automatic positive airway pressure (APAP) device (S9 AutoSet; ResMed)
排除标准
- •1. Refusal or unable to participate
- •2. First-line nasal mask other than those being assessed
- •3. Patient previously treated with CPAP/APAP or noninvasive positive pressure ventilation
- •4. Has undergone Ear, nose and throat (ENT) surgery within the previous 6 weeks
- •5. Significant epistaxis in the previous 6 months,
- •6. Patient participating in another clinical trial
研究者
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