Prevalence of Metabolic Syndrome in Obstructive Sleep Apnea and the Effect of Treatment With Auto-titrating Continuous Positive Airway Pressure (Auto-CPAP) on Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Proportion of subjects satisfying the National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP III) criteria for the diagnosis of metabolic syndrome
研究概览
简要总结
Metabolic syndrome is a constellation of risk factors for cardiovascular disease. The prevalence of metabolic syndrome in persons with obstructive sleep apnea syndrome (OSAS) is known to be very high, about 70%. However, it is unclear whether this association is causal or not. Results of earlier studies have been conflicting. The investigators hypothesize that treatment with auto-titrating continuous positive airway pressure (auto-CPAP) for a duration of 3 months improves the metabolic syndrome in subjects with OSAS.
详细描述
Obstructive sleep apnea (OSA) is a condition in which there is collapse of the upper airway during sleep, as a result of which there is a decrease or complete cessation of airflow. This leads to repeated episodes of hypoxia during sleep and sleep fragmentation. OSA is a highly prevalent though under-recognized clinical problem. The Wisconsin study estimated a prevalence of 24% in males and 9% in females. A population-based study in Delhi, India found the prevalence of OSA to be 13.7% and that of obstructive sleep apnea syndrome (OSAS) to be 3.8%.
OSA is associated with various systemic complications such as neurocognitive dysfunction, cardiovascular disease, insulin resistance, and dyslipidemia. There is an increased risk of motor vehicle and occupational accidents in people suffering from OSAS.
Metabolic syndrome is the co-occurrence of several cardiovascular risk factors such as abdominal obesity, hypertension, impaired glucose tolerance and dyslipidemia. Presence of OSA together with metabolic syndrome is known as 'Syndrome Z'. Although many studies have shown that OSA is associated with metabolic syndrome, the exact causal relationship between these two entities is not proven.
Continuous positive airway pressure (CPAP) is the standard treatment for OSA with significant symptoms. However, it is a costly treatment option, and poor compliance is an important limiting factor. CPAP treatment has been shown to improve the daytime somnolence and neurocognitive function in people with OSAS. However, its effect on metabolic syndrome in people with OSAS is unclear.
This study aims to assess the effect of CPAP treatment on metabolic syndrome in patients with OSAS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with moderately severe OSAS (AHI >= 15 with excessive daytime sleepiness) also having metabolic syndrome, and have never received treatment for OSAS, diabetes mellitus and hypertension
排除标准
- •Diabetic subjects will be excluded if any one of the following is present
- •Proliferative diabetic retinopathy
- •Nephropathy (serum creatinine >1.8 mg/dL)
- •Clinically manifest neuropathy defined as absent ankle jerks.
- •Severe hyperglycemia (FBS >200 mg/dL)
- •Hypertensive subjects will be excluded if any one of the following is present
- •Symptomatic coronary artery disease
- •Symptomatic peripheral vascular disease
- •Past history of cerebrovascular accident
- •Known case of aortic aneurysm or left ventricular dysfunction
- •Nephropathy (serum creatinine >1.8 mg/dL)
- •Marked elevation in blood pressure (BP >180/110 mm Hg on two occasions)
结局指标
主要结局
Proportion of subjects satisfying the National Cholesterol Education Program-Adult Treatment Panel (NCEP-ATP III) criteria for the diagnosis of metabolic syndrome
时间窗: 3 months
次要结局
- Individual components of the NCEP-ATP III criteria (FBS, BP, LDL cholesterol, HDL cholesterol, triglycerides) and insulin resistance (assessed by HOMA-IR)(3 months)
研究者
S.K.SHARMA
Professor and Head
All India Institute of Medical Sciences, New Delhi