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临床试验/NCT02919930
NCT02919930招募中不适用

Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Apnea/hypopnea index

研究概览

简要总结

The purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. In the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. In the second group, patients will use an oronasal mask first and a nasal mask during the second night. The results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • Patients with central sleep apnea, not responding to treatment with CPAP
  • Indication for treatment with ASV

排除标准

  • Patients < 18 years old

结局指标

主要结局

Apnea/hypopnea index

时间窗: Two nights

Effect on respiratory events

次要结局

  • Sleep architecture(Two nights)
  • Mask comfort VAS(Two nights)
  • Device leaks data(Two nights)
  • Sleep efficiency(Two nights)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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