ACTRN12616001153404招募中未知
A randomised clinical trial to evaluate the effects of continuous positive airway pressure (CPAP) on nocturnal beat to beat blood pressure and vascular function in patients with obstructive sleep apnoea.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 16
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
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Participants will be individuals with obstructive sleep apnoea and who have been established on Continuous positive airway pressure (CPAP) therapy within the last three years. They will also need to be compliant with CPAP therapy (average nightly use > 4 hours per night at the last review). Only participants whose CPAP therapy has been shown to be effective (i.e., residual AHI <10/hr on CPAP machine download or polysomnographic assessment of control of OSA while using CPAP) will be included.
排除标准
- •1. Current smoker
- •2. Alcohol consumption more than 21 standard units per week
- •3. Significant cardiovascular disease including unstable angina, cardiac failure (NYHA > level 2), important arrhythmia (e.g. atrial fibrillation (AF), 2nd, 3rd degree heart block), history of myocardial infarction (MI) within last 3 months and previous history of stroke.
- •4. Severely and inadequately controlled hypertension (i.e. BP >180/110 mmHg).
- •5. Severe respiratory disease but excluding those with more than moderate obstructive lung disease i.e. reduced ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC ratio) and FEV1 < 50% or moderate restrictive lung disease i.e. FVC or total lung capacity (TLC < 50%). However stable lung disease with less severe disease can be recruited.
- •6. Severe nocturnal desaturation documented on polysomnography (PSG) > 2% night sleep-time with arterial oxygen saturation of <85%.
- •7. Central (non-obstructive) sleep apnoea (central events > 50% AHI or > 15 events/hour).
- •8. Predominant Cheyne-Stokes respiration.
- •9. Other serious medical disorders (disabling neurological disorders, life threatening malignancy, renal failure requiring dialysis, peripheral artery diseases and etc.)
- •10. Change of medication in the last 3 months
- •11. Morbid obesity (BMI> 40kg/m2).
- •12. OSA not primary sleep disorder, i.e. exclude if primary insomnia diagnosis, narcolepsy or primary restless legs/ periodic limb movement syndrome (PLMS).
- •13. Professional drivers.
- •14. Raynaud's phenomenon.
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