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
- 1
- 主要终点
- Change from baseline flow-mediated vasodilation 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
- •Adults aged 21-80 years.
- •Participants with a previous diagnosis of moderate to severe obstructive sleep will be eligible to enroll and attend the baseline study. Patients with a total apnea-hypopnea index greater than 15 events/hr on the baseline study will be eligible for further participation.
排除标准
- •Current treatment for obstructive sleep apnea (including CPAP, oral appliances, supplemental oxygen). Patients must be untreated prior to the baseline visit.
- •Use of medications that might depress respiration (including opioids, barbiturates, benzodiazepines, and Z drugs, including zolpidem, zopiclone, eszopiclone, and zaleplon).
- •Active use of non-prescription opioids (e.g., cocaine, methamphetamine)
- •Uncontrolled medical problem or major organ system disease, which, in the opinion of the investigators (PI and Co-Is), would interfere with the evaluation of the subject (e.g., uncontrolled hypertension, unstable coronary heart disease, etc.).
- •History of congestive heart failure, renal insufficiency, systemic neurological condition that could affect respiration.
- •Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
- •central sleep apnea (>50% of respiratory events scored as central),
- •chronic hypoventilation/hypoxemia (awake SaO2 < 92% by oximetry) due to chronic obstructive pulmonary disease or other respiratory conditions.
- •Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
- •Patients unable or unwilling to use CPAP.
- •Insomnia or insufficient sleep (self-reported inability to sleep >6 hrs night).
- •Pregnancy (women)
研究组 & 干预措施
Positive Airway Pressure Device
All participants will receive PAP therapy
干预措施: PAP (Device)
结局指标
主要结局
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.
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.
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 N-terminal pro b-type natriuretic peptide (NT-proBNP) at 12 weeks(12 weeks)
- Change from baseline Albumin/Creatinine Ratio 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