Sleep position device versus continuous positive airway pressure in mild to moderate central sleep apnea: a randomized trial

Martini Ziekenhuis0 个研究点目标入组 200 人开始时间: 2023年12月11日最近更新: 2024年1月8日

试验速览

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•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

•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 heart failure (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

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