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临床试验/NCT02417584
NCT02417584已完成不适用

The Role of Compliance With Positive Airway Pressure Use on Blood Pressure in Patients With Obstructive Sleep Apnea

University of Crete2 个研究点 分布在 1 个国家目标入组 1,168 人开始时间: 2009年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,168
试验地点
2
主要终点
drop in blood pressure

研究概览

简要总结

The aim of the study was to determine the long term effects of compliance with positive airway pressure therapy on blood pressure in both hypertensive and normotensive patients with obstructive sleep apnoea hypopnoea syndrome.

详细描述

Scientific data about the causal role of obstructive sleep apnoea hypopnoea syndrome (OSAHS) in the development of systemic hypertension and the effects of positive airway pressure (PAP) treatment on blood pressure (BP) control are continuously increasing; however they are controversial. We aimed to determine the long term effects of compliance with PAP therapy on BP in both hypertensive and normotensive patients with OSAHS.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed OSAHS by polysomnography according to standard criteria
  • no history of previous PAP therapy
  • normotensive and hypertensive patients
  • an above-elementary school education.

排除标准

  • refusal to participate
  • refusal of PAP therapy
  • secondary hypertension
  • central sleep apnea syndromes
  • obesity hypoventilation syndrome
  • restrictive ventilator syndromes
  • history of established cardiovascular disease
  • severe congestive heart failure
  • a history of life-threatening arrhythmias
  • severe cardiomyopathy
  • significant chronic kidney disease
  • long-term oxygen therapy
  • family or personal history of mental illness
  • drug or alcohol abuse
  • severe cognitive impairment
  • concurrent oncological diseases
  • need for chronic use of medication that may affect BP levels
  • pregnancy
  • history of narcolepsy or restless leg syndrome

结局指标

主要结局

drop in blood pressure

时间窗: two years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Izolde Bouloukaki

MD, PhD, Consultant at NHS

University of Crete

研究点 (2)

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