Phenotyping Mechanistic Pathways for Adverse Health Outcomes in Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Change from baseline 24-hour mean systolic blood pressure at 12 weeks
研究概览
简要总结
Obstructive sleep apnea (OSA) is a highly prevalent disorder with adverse neurocognitive and cardio-metabolic outcomes. Continuous positive airway pressure (CPAP) is the gold standard therapeutic option to treat airway obstructions during sleep and thus, prevent its adverse cardiovascular and neurocognitive outcomes. Previous clinical trials, however, have largely failed to show a consistent impact of CPAP on these health outcomes.
One of the main limitations of these trials may be the inadequate characterization of OSA and its acute physiological consequences. By characterizing OSA based on the "apnea-hypopnea index (AHI)", there is a potential risk of negative results.
In this trial, the investigators intend to tackle this issue, by better characterization of OSA-related physiological consequences during sleep using physiologically driven metrics to capture the burden of OSA-related hypoxemia ("hypoxic burden"), autonomic response ("heart rate burden"), and sleep fragmentation ("arousal burden").
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline 24-hour mean systolic blood pressure at 12 weeks
时间窗: 12 weeks
Mean systolic blood pressure over a 24-hour period is measured using an ambulatory blood pressure monitor.
Change from baseline Epworth Sleepiness Scale (ESS) at 12 weeks
时间窗: 12 weeks
Self-reported sleepiness measured using the Epworth Sleepiness Scale (units on a scale). Values range from 0-24; higher values indicate greater sleepiness.
Change from baseline flow-mediated vasodilation at 12 weeks
时间窗: 12 weeks
Flow mediated vasodilation is studied using high resolution ultrasound of the artery.
次要结局
- Change from baseline Albumin without Creatinine at 12 weeks(12 weeks)
- Change from baseline Plasminogen Activator Inhibitor-1 at 12 weeks(12 weeks)
- Change from baseline Creatinine at 12 weeks(12 weeks)
- Change from baseline Albumin/Creatinine Ratio at 12 weeks(12 weeks)
- Change from baseline N-terminal pro b-type natriuretic peptide (NT-proBNP) at 12 weeks(12 weeks)
- Change from baseline Hemoglobin A1c (HbA1c) at 12 weeks(12 weeks)
- Change from baseline high sensitivity C-Reactive Protein (hs-CRP) at 12 weeks(12 weeks)
- Change from baseline Fibrinogen Antigen at 12 weeks(12 weeks)
- Change from baseline Cystanin C with eGFR at 12 weeks(12 weeks)
- Change from baseline nocturnal mean diastolic blood pressure at 12 weeks(12 weeks)
- Change from baseline Psychomotor Vigilance Task reaction time at 12 weeks(12 weeks)
- Change from baseline F2-Isoprostane/Creatinine Ratio at 12 weeks(12 weeks)
- Change from baseline Oxidized low-density lipoprotein (LDL) at 12 weeks(12 weeks)
- Change from baseline lipid panel at 12 weeks(12 weeks)
- Change from baseline nocturnal mean systolic blood pressure at 12 weeks(12 weeks)
- Change from baseline nocturnal mean blood pressure at 12 weeks(12 weeks)
- Change from baseline Glucose at 12 weeks(12 weeks)
- Change from baseline Interleukin-6 (IL-6) at 12 weeks(12 weeks)
- Change from baseline 24-hour mean diastolic blood pressure at 12 weeks(12 weeks)
- Change from baseline 24-hour mean blood pressure at 12 weeks(12 weeks)
- Change from baseline Functional Outcome of Sleep Questionnaire (FOSQ) at 12 weeks(12 weeks)
- Change from baseline Psychomotor Vigilance Task lapses per test at 12 weeks(12 weeks)
研究者
Ali Azarbarzin
Associate Scientist
Brigham and Women's Hospital