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临床试验/ISRCTN39453867
ISRCTN39453867已完成不适用

Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial

ResMed0 个研究点目标入组 228 人开始时间: 2015年4月27日最近更新:

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

发起方
ResMed

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