A Randomized Controlled Study on the Effects of Continuous Positive Airway Pressure (CPAP) on Visceral Fat Thickness, Carotid Intima-media Thickness and Adipokines in Patients With Obstructive Sleep Apnoea Syndrome (OSAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Mesenteric Fat Thickness
研究概览
简要总结
We hypothesize that patients with untreated OSAS will have more visceral fat, fatty liver and increased carotid artery thickness whereas treatment with CPAP may reduce the mesenteric and liver fat, plasma lipids, carotid artery thickness.
详细描述
This proposed randomized control trial (RCT) will compare the effects of therapeutic CPAP versus subtherapeutic CPAP in patients newly diagnosed with OSA with reference to visceral fat especially mesenteric fat thickness, liver fat, carotid artery intima media thickness (IMT), lateral pharyngeal wall (LPW) thickness, plasma lipids and adipokines over a treatment period of 3 months. The results of this study will advance our understanding of the relative role of OSA and obesity in the pathogenesis of metabolic syndrome (MetS) and whether CPAP therapy can improve these metabolic dysregulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic patients with OSA of apnea hypopnea index (AHI) >= 5/hr
排除标准
- •Recent or past history of myocardial infarction/stroke/heart failure, unstable angina, underlying malignancy,
- •patients with clinical features of any active infection
- •those who require urgent CPAP treatment because of associated respiratory failure or to prevent job loss through excessive daytime sleepiness (eg professional drivers, those handling dangerous machinery)
- •moderate to severe valvular heart disease, cardiomyopathy, and previous diagnosis of OSA and/or previous use of CPAP therapy.
研究组 & 干预措施
Therapeutic CPAP
Therapeutic CPAP
干预措施: CPAP (Device)
control
subtherapeutic CPAP using 4 cm water
干预措施: CPAP (Device)
结局指标
主要结局
Mesenteric Fat Thickness
时间窗: 3 months
次要结局
- Mean Changes in Adiponectin Over 3 Months(Baseline, 3 months)
研究者
Prof David Shu Cheong Hui
Professor
Chinese University of Hong Kong