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临床试验/NCT02930460
NCT02930460终止不适用

Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure, Treated With Bilevel Positive Airway Pressure (AirCurve 10 VAutoTM) as Second-line Therapy: PoP IN VAuto

ResMed8 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
ResMed
入组人数
30
试验地点
8
主要终点
Compliance

研究概览

简要总结

Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM

详细描述

To characterize, in routine practice, non compliant patient to continuous positive airway pressure who can get a benefit of a bilevel positive airway pressure therapy as a second line treatment (Aircurve 10 VAutoTM ) To evaluate the clinical management of obstructive sleep apnea patients treated by Aircurve 10 VAutoTM , especially impact on compliance and residual apnea hypopnea Index.

To evaluate Aircurve 10 VAutoTM benefit on quality of Life and quality of sleep

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patient
  • Obstructive Sleep Apnea Patient previously treated by Continuous positive airway pressure non-compliant to therapy
  • Patient naive of bilevel Positive Airway Pressure therapy

排除标准

  • Bilevel positive airway pressure Contraindication
  • Severe respiratory disease diagnostic

结局指标

主要结局

Compliance

时间窗: 3 months

hours of usage of the device per night

次要结局

  • sleepiness(3 months)
  • sleep quality(3 months)

研究者

发起方
ResMed
申办方类型
Industry
责任方
Sponsor

研究点 (8)

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