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临床试验/NCT06172998
NCT06172998招募中早期 1 期

New Perspective on Exploring the Post-apneic Blood Pressure Surge in Patients With Obstructive Sleep Apnea

Xu J1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
早期 1 期
状态
招募中
发起方
入组人数
350
试验地点
1
主要终点
Number of Participants with high nocturnal short-term BPV will change

研究概览

简要总结

The nocturnal short-term BPV induced by sleep-breathing events is affected by many factors. The purpose of the study is as follows: (1) to explore the relationship between nocturnal short-term BPV and vascular endothelial function and sympathetic activity in patients with OSA respectively, (2) to explore which play the key role in BP fluctuation, (3) how to prevent the frequent BP fluctuation and arrive at a safe point.

详细描述

It has been known that nocturnal short-term blood pressure variability (BPV) is a special phenomenon in obstructive sleep apnea (OSA) patients. Nocturnal short-term BPV is a quantitative measure that describes the BP fluctuation over a period of seconds to minutes. It is significantly associated with target organ injury, increased risk of cardio-cerebrovascular events, and increased mortality, independent of mean BP level. Our prior study found that nocturnal BP will temporarily reach the peak during one OSA episode and come to decline rapidly. However, this phenomenon does not occur in all OSA patients. In some severe OSA patients with severe hypoxemia, their BP can still maintain a relatively stable level when one OSA episode. The specific mechanism is still unclear. In physiological conditions, the BP fluctuation caused by each cardiac cycle is affected by vascular function, central sympathetic, arterial reflex, cardiopulmonary reflex, elastic properties of arteries, humoral, and even emotional factors. Therefore, the purpose of the study is as follows: (1) to explore the relationship between nocturnal short-term BPV and vascular endothelial function and sympathetic activity in patients with OSA respectively, (2) to explore which play the key role in BP fluctuation, (3) how to prevent the frequent BP fluctuation and arrive at a safe point.

First, about 300 suspected OSA and 50 healthy subjects under full-night polysomnography (PSG) will be recruited in the sleep medicine center of The Affiliated Huai'an No. 1 People's Hospital of Nanjing Medical University and The First Affiliated Hospital with Nanjing Medical University. All the participants complete the questionnaire which includes clinical medical history, sleep habits, general health, smoking and drinking history, and anthropometric data. When PSG worked, BP was calculated by pulse transit time (PTT) simultaneously and continuously. The electrocardiography data extracted from the entire overnight PSG recordings are visually inspected for accuracy and quality and used for heart rate analysis (HRV) analysis. The next day, 4-5 mL peripheral venous blood samples are obtained from participants in the morning after an overnight fast and used for biochemical analysis. The sympathetic activity could be represented by HRV and Norepinephrine detected by enzyme-linked immunosorbent. Then, brachial artery diameter will be measured after the reactive hyperemia (called flow-mediated dilation, FMD) and nitroglycerin stimulus (called nitroglycerin-mediated dilation, NMD). The FMD and NMD could represent the vascular function. About 80 patients will be in the next plan. On the second day, under patient safety, Phentolamine will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent sympathetic overactivity. On the third day, under patient safety, Nitroglycerin will be pumped into the OSA patients equipped with PSG and ECG monitoring in a safe dose to prevent endothelial dysfunction. The parameters before and after medicine will be analyzed and compared.

Hypothesis

The investigator predicted that patients who received phentolamine and nitroglycerin injections would lower nocturnal short-term BPV measured by polysomnography

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • medium to severe OSA (apnea-hypopnea index, AHI≥15 events/h) and patients without OSA (AHI<5 events/h)
  • age from 18 to 65 years old.

排除标准

  • combined with other sleep disorders
  • patients with comorbidities, such as hypertension, diabetes, cardiovascular diseases, and cerebrovascular diseases etc
  • conditions that potentially affect the accuracy of BPV and endothelial function
  • ever-received the treatment of constructive positive airway pressure (CPAP)
  • who refuse to participate in the study.

研究组 & 干预措施

high BPV group

Experimental

干预措施: Phentolamine Injection (Drug)

结局指标

主要结局

Number of Participants with high nocturnal short-term BPV will change

时间窗: one night

次要结局

未报告次要终点

研究者

发起方
Xu J
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xu J

professor

Huai'an No.1 People's Hospital

研究点 (1)

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