跳至主要内容
临床试验/NL-OMON20065
NL-OMON20065尚未招募不适用

Sleep Position Device Versus Continuous Positive Airway Pressure in Mild to Moderate Central Sleep ApneaA Randomized Trial

one0 个研究点目标入组 200 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
one
入组人数
200

研究概览

简要总结

Final results will be published in peer reviewed medical journal

研究设计

研究类型
Interventional

入排标准

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • 1. Patients with central positional sleep apnoea are included in the study.
  • 2. Apnoehypopneuindex = 5 AND = 30.
  • 3. Patient age = 18.
  • Central sleep apnoea is defined as: AHI = 5 with 50% or more of events occurring without any respiratory effort. And associated with symptoms of either excessive sleepiness or disrupted sleep.
  • Positional sleep apnoea is defined as having a supine AHI=2x AHI non-supine with =10% and = 90% supine sleep

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • 1. chronic respiratory insufficiency (paCO2 > 6kPA)
  • 2. BMI = 30
  • 3. Left sided valvular heart disease > mild
  • 4. Patients with symptomatic heartfailure (AHA stadium C)
  • 5. Night or rotating shift work
  • 6. Active psychiatric disease
  • 7. Seizure disorder
  • 8. Medication use for sleeping disorders
  • 9. Previous treatment with CPAP or sleep position device
  • 10. Simultaneous other OSAS treatments
  • 11. Pregnancy
  • 12. Coexistent non-respiratory sleep disorders (e.g. insomnia, periodic limb movement disorder, narcolepsy) that would influence functional sleep assessment

研究者

发起方
one

相似试验

Sleep Position Device Versus Continuous Positive... | 临床试验