跳至主要内容
临床试验/NCT05155813
NCT05155813Unknown不适用

Prevalence of Sleep Apnea Among Consecutive Patients With Atrial Fibrillation.

Brigham and Women's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Prevalence of sleep apnea

研究概览

简要总结

The investigators will screen consecutive patients presenting to the atrial fibrillation clinic for sleep apnea using a FDA-approved home sleep testing device, WatchPAT to determine prevalence of sleep apnea in a clinic-based sample.

详细描述

The investigators will determine the prevalence of sleep apnea among consecutive patients with atrial fibrillation (AF) regardless of symptoms and determine the predictive value of screening tools for sleep apnea in this population. The primary outcome will be the prevalence of sleep apnea among all-comers with AF. Three secondary outcomes will be evaluated in the study. Investigators will determine the efficiency and time-to-diagnosis of sleep apnea using a FDA approved home sleep testing device (i.e. WatchPAT). These analyses will be compared to published studies performed using a traditional home sleep study test (which historically takes approximately 8-10 weeks). There will be no collection of data from a non-intervention group in our study. Second, investigtaors will calculate the predictive value of traditional clinical screening tools in an AF population using the STOP-BANG questionnaire and Epworth Sleepiness Scale. Third, investigators will identify potential risk factors for AF in patients with sleep apnea using a logistic regression model.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Diagnosis of AF confirmed on any electrocardiographic recording
  • Age greater than or equal to 18
  • Ability to read and understand consent form, complete questionnaires, and provide informed consent

排除标准

  • Prior diagnosis of sleep disordered breathing or negative testing within the past 2 years without significant change in weight or clinical symptoms of sleep apnea
  • History of Raynaud

结局指标

主要结局

Prevalence of sleep apnea

时间窗: 2 year study

Prevalence of sleep apnea among patients with atrial fibrillation

次要结局

  • Quality of life(2 years)
  • Time to diagnosis(2 years)
  • Risk factors(2 years)
  • Predictive value of typical screening tools(2 years)

研究者

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

Sogol Javaheri

Principal Investigator

Brigham and Women's Hospital

研究点 (1)

Loading locations...

相似试验