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临床试验/ACTRN12620000050954
ACTRN12620000050954招募中未知

Impact of optimized Obstructive Sleep Apnea Therapy in Patients with Acute Coronary Syndrome: A Pilot Randomised Control Trial

niversity of Sydney0 个研究点目标入组 60 人开始时间: 2020年1月22日最近更新:
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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