跳至主要内容
临床试验/NCT00263757
NCT00263757已完成不适用

A Randomized Trial of Positive Airway Pressure Therapy In Atrial Fibrillation Recurrence In Sleep Apnea

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
25
试验地点
2
主要终点
Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year

研究概览

简要总结

This randomized, controlled trial is designed to test whether treatment of sleep disordered breathing (SDB) with positive airway pressure (PAP) therapy alters the natural history of atrial fibrillation (AF). Patients with recent AF who are now in sinus rhythm, and found to have SDB (obstructive and/or central sleep apnea) by formal sleep study but without complaints of daytime sleepiness, are randomized to PAP therapy to eradicate SDB or to usual care (medical management as prescribed by the patient's cardiologist).

详细描述

Sleep apnea is a common disorder which is increasingly implicated in the pathogenesis of cardiovascular disease. Observational data suggest that sleep apnea may play a role in the development of atrial fibrillation (AF), and may even predispose to recurrence of AF following electrical cardioversion (DCCV). Because of biases and confounders inherent to observational studies, we propose a randomized clinical trial to assess the effects of treatment of sleep apnea in subjects with AF treated with DCCV. Following polysomnography, subjects with sleep apnea will be randomized to positive airway pressure (PAP) or usual medical care and followed for up to one year to compare a primary outcome of AF recurrence rate.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of Subjects Who Had Atrial Fibrillation Recurrence at 1 Year

时间窗: 1 year

次要结局

  • Mean Score on Functional Outcomes of Sleep Questionnaire (FOSQ)(baseline, 12 months)
  • Mean Score on Epworth Sleepiness Scale (ESS) at Baseline and 12 Month Visit(baseline, 12 months)

研究者

发起方
Mayo Clinic
申办方类型
Other

研究点 (2)

Loading locations...

相似试验