Comorbid Insomnia and Sleep Disordered Breathing in Patients Undergoing Cardiac Rehabilitation: Prevalence and Impact on Cardiovascular Risk Profile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- The combination of both sleep disorders will be associated with more detrimental CV risk markers (lipids) than either sleep disorder alone
研究概览
简要总结
The purpose of this research is to determine how frequently sleep disorders such as sleep disordered breathing and insomnia occur in patients with coronary artery disease enrolled in cardiac rehabilitation. By reviewing results of a variety of tests, we also hope to learn more about the cardiovascular effects on people who may have these conditions.
详细描述
Patients referred to the Mayo Clinic Rochester CR and meeting eligibility criteria (see Subjects section below) will be recruited and consented. Prior to beginning CR, enrolled patients will undergo baseline sleep and CV assessment at the Clinical Research and Trials Unit (CRTU). Home-based sleep monitoring will take place. Patients will also complete additional cardiometabolic and behavioral evaluation as part of the standard CR clinical care. Following completion of the 12-week CR program, a post-CR assessment may be conducted, including the same set of tests/procedures. All patients will be followed up for at least 6-months following enrollment to monitor cardiac recurrence, hospitalization and death.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be >18 years old
- •Referred to CR following admitted to the hospital with a documented diagnosis of acute coronary syndrome
- •Referred to CR following admission to the hospital with a documented diagnosis of ST- elevation myocardial infarction (STEMI),
- •Referred to CR following admission to the hospital with a documented diagnosis of non- STEMI
- •Referred to CR following admission to the hospital with a documented diagnosis of unstable angina
- •Referred to CR following admission to the hospital with a documented diagnosis of post coronary artery bypass surgery
- •Referred to CR following admission to the hospital after percutaneous coronary intervention (with or without stent placement).
排除标准
- •heart failure with reduced ejection fraction
- •peripheral artery disease
- •valve or pericardial surgery
- •heart transplantation
- •patients unable to provide informed consent
- •patients unable to speak and read English
- •night shift workers
- •pregnant women
- •those who will only attend full home-based CR.
结局指标
主要结局
The combination of both sleep disorders will be associated with more detrimental CV risk markers (lipids) than either sleep disorder alone
时间窗: 6 months
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
The combination of both sleep disorders will be associated with lower adherence to CR - exercise
时间窗: 6 months
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to the exercise prescription than those without
The combination of both sleep disorders will be associated with lower adherence to CR - number of attended sessions
时间窗: 6 months
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to CR attendance than those without
The combination of both sleep disorders will be associated with more detrimental CV risk markers (blood pressure) than either sleep disorder alone
时间窗: 6 months
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
The combination of both sleep disorders will be associated with lower adherence to CR - dietary prescription
时间窗: 6 months
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to dietary recommendations than those without
The combination of both sleep disorders will be associated with more detrimental CV risk markers (cardiorespiratory fitness) than either sleep disorder alone.
时间窗: 6 months
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without.
To examine the prevalence of comorbid sleep disordered breathing and insomnia in post-MI patients enrolled in cardiac rehab.
时间窗: 6 months
Comorbid SDB and insomnia will be highly prevalent (\>30%) in this population. Measured by home, overnight polysomnography
The combination of both sleep disorders will be associated with more detrimental CV risk markers (depression) than either sleep disorder alone
时间窗: 6 months
To assess whether post-MI CR patients with comorbid SDB and insomnia exhibit a more unfavorable CV profile than those without using the PHQ-9.
The combination of both sleep disorders will be associated with lower adherence to CR - adherence to pharmacotherapy
时间窗: 6 months
To determine whether post-MI CR patients with comorbid SDB and insomnia show less adherence to prescribed medications than those without
次要结局
未报告次要终点
研究者
Amanda R. Bonikowske
Assistant Professor of Medicine
Mayo Clinic