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
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
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