ACTRN12620000050954招募中未知
Impact of optimized Obstructive Sleep Apnea Therapy in Patients with Acute Coronary Syndrome: A Pilot Randomised Control Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years(—)
- 性别
- All
入选标准
- •1. Patients with a recent (within 12 months of diagnosis) presentation of acute coronary syndrome (unstable angina, ST elevated myocardial infarction (EMI), non-STEMI).
- •2. Patients diagnosed with moderate to severe obstructive sleep apnoea with significant hypoxia defined as an Oxygen Saturation Index 3% (ODI 3%) > 10 events/hour on polysomnogram.
- •3. Clinically suitable for PAP and/or OAT treatment.
- •4. Willingness to undergo either PAP, OAT or usual care for 6 months.
排除标准
- •1. Previous treatment for obstructive sleep apnea.
- •2. Contraindications to CPAP (severe nasal obstruction) or oral appliance therapy (insufficient teeth or dental health issues).
- •3. Women who are lactating or pregnant
- •4. Driving risk, report an accident (or near miss accident) because of sleepiness in the last 6 months
- •5. Need for immediate therapy as assessed by treating sleep physician.
- •6. Patients with a history of psychological illness or conditions such as to interfere with the patients ability to understand the requirements of the study
- •7. Coexisting sleep disorder, shift work, regular use of sedatives or narcotics, pre-existing lung disease (moderate to severe chronic obstructive pulmonary disease) or psychiatric disease; chronic kidney disease (eGFR<60).
- •8. Central sleep apnea (defined as >20% of respiratory events being central events, rather than obstructive events)
研究者
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