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临床试验/NCT03011294
NCT03011294已完成4 期

Cardiovascular Impact, Quality e Quantity of Sleep in Bed Partners of Patients With Obstructive Sleep Apnea: a Randomized Study

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Endothelial function (forearm dilation, FMD - %)

研究概览

简要总结

Obstructive sleep apnea (OSA) is a common clinical condition associate with a negative impact not limited to the patients but also to the partner that sleep in the same bed. Is it reasonable to speculate that the partner suffer sleep deprivation, increased level of irritability, insomnia, fatigue, among others due to the loud snoring caused by the OSA patient. Although previous data reported impaired sleep quality in partners of patients with OSA, it is not clear in literature whether OSA promotes cardiovascular impact and if the treatment of OSA promotes some cardiovascular benefits in (the) partner beyond the improvements in the subjective and objective sleep. Thus, the main objectives of this randomized controlled study are: to evaluate the impact of three months of randomization (treatment with nasal CPAP or nasal strips) on the endothelial function, blood pressure (ambulatory blood pressure monitoring), sleep duration (wrist actigraphy for 1 week) and sleep quality (Pittsburgh Questionnaire) and the frequency of OSA in the bed partners of patients with moderate to severe OSA.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Bed partners of patients with moderate to severe OSA

排除标准

  • Bed partners with OSA using specific treatment.

结局指标

主要结局

Endothelial function (forearm dilation, FMD - %)

时间窗: 3 months

次要结局

  • Frequency of OSA(Baseline only)
  • Ambulatory blood pressure monitoring (ABPM)(3 months)
  • Sleep quantity (measured by actigraphy - hours/night)(3 months)
  • Sleep quality (Pittsburgh Questionnaire)(3 months)

研究者

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

Luciano F Drager, MD, PhD

Associate Professor of Medicine

University of Sao Paulo

研究点 (2)

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