ACTRN12618000227291终止未知
A randomised evaluation of the effectiveness of continuous positive airway pressure therapy in participants with obstructive sleep apnoea and angina, and no obstructive coronary artery disease.
niversity of Adelaide0 个研究点目标入组 42 人开始时间: 2018年2月12日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 42
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 80 Years（—）
- 性别
- All
入选标准
- •1. Met NOCAD1 study inclusion criteria:
- •- Clinical diagnosis of angina
- •- Persistent angina
- •- Coronary angiography demonstrating normal or no obstructive coronary disease (<50% diameter stenosis)
- •2. Participants for CPAP therapy with obstructive sleep apnoea diagnosis
- •- AHI<20; REM-AHI>45
- •3. Patients are able and willing to give appropriate informed consent.
排除标准
- •1. Met NOCAD1 study exclusion criteria:
- •- Admission for an acute coronary syndrome within the preceding month
- •- Prior coronary artery bypass grafting
- •- Contra-indications to coronary haemodynamic assessment - patients with permanent pacemaker or de brillator, severe renal or hepatic insu ciency, severe asthma, left ventricular systolic dysfunction (ejection fraction <50%)
- •- Alternative coronary explanations for the chest pain - obstructive coronary artery disease (Flow limiting coronary stenosis i.e. derived fractional flow reserve (FFR) <0.80), spontaneous coronary spasm (but not catheter related spasm), spontaneous coronary artery dissection
- •- Other cardiovascular disorders - pulmonary hypertension, pulmonary embolism, hypertrophic cardiomyopathy, or valvular heart disease.
- •2. Non-English speaking patient
- •3. Unable to give consent due to cognitive impairment
- •4. Patient is or may be pregnant
- •5. Severe comorbidity with severe disability or likelihood of death
- •6. Significant memory, perceptual or behavioural disorder
- •7. Neurological deficit preventing self administration of CPAP mask
- •8. Contra-indication to CPAP use e.g. pneumothorax
- •9. Severe respiratory disease defined as
- •- Severe chronic obstructive pulmonary disease (FEV1/FVC<70% and FEV1 <50% predicted)
- •- Resting SaO2 <90%.
- •10. Prior use of CPAP treatment of OSA
- •11. Increased risk of a sleep-related accident and/or excessive daytime sleepiness, defined by any one of the following:
- •- Driver occupation (eg truck, taxi)
- •- ‘fall asleep’ accident or ‘near miss’ accident in previous 12 months
- •- High Epworth Sleepiness Scale score (>15)
- •12. Severe nocturnal desaturation documented during sleep study as >10% overnight recording time with arterial oxygen saturation of <80%
- •13. Cheyne-Stokes Respiration (CSResp)
研究者
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