Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Mean oxyhemoglobin saturation (percent) during sleep
研究概览
简要总结
Overall objective: To understand the feasibility of performing a randomized trial using a simple, minimally-invasive postural therapy approach to improve sleep disordered breathing (SDB).
详细描述
Specific Aims:
- To examine the relative efficacy of postural therapy (a 15-degree wedge mattress) on measures of chronic cardiometabolic stress in high altitude residents.
- To determine the tolerability of postural therapy.
Primary outcomes, at 4 and 8 weeks:
- Mean nocturnal oxyhemoglobin saturation (SPO2)
- Apnea-hypopnea index (AHI).
Secondary outcomes
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
- Single (Outcomes Assessor)
盲法说明
Subjects will undergo sleep study in subjects' randomized sleep posture. Randomization will be recorded separately from sleep study recordings. These recordings will be reviewed by trained sleep study technicians who will be blinded to randomization. Blood samples will also be assayed for markers of glucose control.
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in Mean oxyhemoglobin saturation (percent) during sleep
时间窗: Baseline, 4 weeks, 8 weeks
The investigators will measure mean oxyhemoglobin saturation (%SaO2) during sleep as assessed by WatchPAT home sleep study at baseline and week 8.
Change in Respiratory Disturbance Index (RDI)
时间窗: Baseline, 4 weeks, 8 weeks
The investigators will measure a change in Respiratory Disturbance Index (RDI) defined as an oxygen desaturation of at least 4 percent associated with autonomic signs of arousal. Specifically, autonomic arousals are defined as concurrent rises in heart rate and attenuation of arterial tonometry. Normal \< 5 percent 5 percent \< Mild \< 15 percent 15 percent \< Moderate \< 30 percent Severe \> 30 percent
次要结局
- Change in soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations(Baseline, 8 weeks)
- Change in average plasma hemoglobin concentration (g/dL)(Baseline, 8 weeks)
- Change in average Glycated hemoglobin test (HbA1c)(Baseline, 8 weeks)
- Change in serum erythropoietin (EPO) concentration(Baseline, 8 weeks)
- Change in plasma low-density lipoprotein (LDL) cholesterol level (mg/dL)(Baseline, 8 weeks)
- Tolerability of postural therapy as assessed by adherence monitor(2, 4, 6 and 8 weeks)
- Change in homeostatic model assessment of insulin resistance (HOMA-IR)(Baseline, 8 weeks)
- Change in total plasma cholesterol level (mg/dL)(Baseline, 8 weeks)
- Change in Vascular endothelial growth factor receptor 1 (SVEGF-R1) concentration(Baseline, 8 weeks)
- Change in mean blood pressure (mmHg)(Baseline, 8 weeks)
- Change in Brachial Artery Reactivity Testing (BART) assessment(Baseline, 8 weeks)
- Change in plasma high-density lipoprotein (HDL) cholesterol level (mg/dL)(Baseline, 8 weeks)
- Change in plasma triglyceride concentration (mg/dL)(Baseline, 8 weeks)