Sleep Disordered Breathing in Marfan Syndrome: Susceptibility and Hemodynamics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Pleural Pressure (Pes)
研究概览
简要总结
Upper airway obstruction (UAO) is an unrecognized source of hemodynamic stress that may contribute to aortic adverse events in persons with Marfan Syndrome (MFS). UAO occurs during snoring and sleep apnea and is characterized by repetitive partial or complete obstruction of the upper airway during sleep. These obstructive breathing events lead to intermittent surges in blood pressure (BP) REF and large decreases in pleural pressure (Pes), thereby increasing the trans-mural aortic pressure (TMP) and imposing mechanical stress on the aorta during sleep. Although UAO is known to increase mechanical stress on the aorta, the magnitude of the increase is not known for persons with MFS.
In this project, therefore, the investigators will also examine the changes in Pes and BP responses in periods of obstructed breathing and compare the diurnal markers or vascular stress between Baseline and CPAP studies in MFS persons.
详细描述
Research Objective/Significance:
Specific Aim 1a: To quantify the Pes and BP during periods with and without UAO during sleep in persons with MFS.
Specific Aim 1b: To examine the effect of CPAP treatment of UAO on Pes and BP in MFS persons.
Specific Aim 2: To examine the effect of CPAP treatment of UAO on daytime markers of hemodynamic stress (augmentation index, reactive hyperemia index) in MFS persons.
Primary Outcomes:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People with Marfan syndrome.
- •Age ≥ 18yrs
- •Able and willing to provide informed consent
- •Willing to sleep connected to research apparatus
排除标准
- •Unstable cardiovascular disease (CHF, myocardial infarction or revascularization procedures, and unstable arrhythmias)
- •Uncontrolled hypertension (BP > 190/110)
- •Underlying obstructive or other intrinsic lung disease
- •Renal failure on dialysis
- •Cirrhosis
- •Pregnancy
结局指标
主要结局
Pleural Pressure (Pes)
时间窗: Overnight on both CPAP and No CPAP nights
Pleural pressure (Pes) in mmHg monitored using an esophageal catheter.
Mean Arterial Blood Pressure (MAP)
时间窗: Overnight on both Baseline and CPAP studies
Continuous blood pressure monitored using a non-invasive finger cuff. Data captured in mmHg.
次要结局
- Augmentation Index (AI)(15 minutes in the morning post Baseline and CPAP studies)
- Reactive Hyperemia Index (RHI)(15 minutes)