Noctural Pulse Waves Variations in OSA as a Predictor of Autonomic and Vascular Response to CPAP Therapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change in flow-mediated dilation
研究概览
简要总结
The goal of this clinical trial is to assess the effect of CPAP withdrawal on vascular and autonomic function in patients with obstructive sleep apnea. The main question it aims to answer is:
• Is the pulse wave amplitude index able to predict the impact of sleep apnea treatment withdrawal (continuous positive airway pressure, CPAP) on endothelial function and baroreflex sensitivity?
Participants will stop using their CPAP for 2 weeks and the investigators will assess vascular and autonomic function before and after the withdrawal. Researchers will compare endothelial and autonomic function at baseline and after 2 weeks of withdrawal to see if there are differences. Moreover, they will assess the association between pulse wave amplitude drop profile and effect of CPAP withdrawal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Age ≥18 years old
- •Diagnosed with OSA (AHI ≥15 events/h), confirmed during screening period
- •Adequately treated with CPAP therapy for ≥6 months
- •Able to give informed consent as documented by signature
排除标准
- •Professional drivers will be excluded from the study because temporary withdrawal of CPAP may induce drowsiness.
- •We will also exclude patients with conditions that may affect endothelial and autonomic function:
- •Known Diabetes
- •Known heart failure
- •Known chronic kidney disease
- •Pregnant or lactating women
- •Morbid obesity (≥40 kg/m2)
- •Known Excessive alcohol consumption
- •Known Dementia (especially dementia with Lewy bodies). (61)
- •Patients using alpha and beta blockers
- •Known atrial fibrillation
- •Inability to follow the procedures of the study due to language problems or psychological disorders.
结局指标
主要结局
Change in flow-mediated dilation
时间窗: Between FMD measured after 2 weeks of CPAP withdrawal and FMD measured after 2 weeks on CPAP
Endothelial function as measured with flow-mediated dilation
Change in the slope of baroreflex sensitivity
时间窗: Between BRS measured after 2 weeks of CPAP withdrawal and BRS measured after 2 weeks on CPAP
Autonomic function as measure with the slope of BRS
次要结局
- Nocturnal heart rate variability indices (linear and non linear)(baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP)
- Hypoxic burden(baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP)
- Change in heart rate response to the cold pressure test(baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP)
- Arterial stiffness assessed by the pulse transit time(Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP)
研究者
Raphael Heinzer
Professor
University of Lausanne Hospitals