Sleep Patterns as Predictive Markers of Hospitalization or Death Due to Cardiovascular Disease in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to learn if there are predictive markers of hospitalization or death that can be found from data gathered from a Sleep Number® bed. This is a prospective observational cohort study that will follow participating subjects in the Masonic Homes/Acacia Creek Retirement Community in Union City, California.
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
- 否
入选标准
- •Subjects living at Masonic Homes/Acacia Creek Retirement Community who use a Sleep Number® bed and are cognitively able to consent on their own accord.
排除标准
- •Subjects who do not have a Sleep Number® bed.
- •Subjects without an internet connection to transmit nightly SleepIQ® data.
结局指标
主要结局
Mortality
时间窗: 5 years
Total number of subject deaths due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation and sudden cardiac death.
Number of subject hospitalizations
时间窗: 5 years
Total number of subjects that required hospitalization due to medical conditions including congestive heart failure, myocardial infarction, atrial fibrillation, and sudden cardiac death.
次要结局
- Change in daytime sleepiness(Baseline, every 6 months for 5 years)
- Change in alertness(Baseline, every 6 months for 5 years)
- Change in depression symptom severity(Baseline, every 6 months for 5 years)
- Change in sleep quality(Baseline, every 6 months for 5 years)
- Change in Attention-deficit/hyperactivity disorder (ADHD) symptom severity(Baseline, every 6 months for 5 years)
- Change in Verbal Memory(Baseline, every 6 months for 5 years)
- Change in Visual Memory(Baseline, every 6 months for 5 years)
- Change in Executive Function(Baseline, every 6 months for 5 years)
- Change in Motor Skills(Baseline, every 6 months for 5 years)
- Change in Processing Speed(Baseline, every 6 months for 5 years)
- Change in Stroop Task(Baseline, every 6 months for 5 years)
- Change in Vigilance(Baseline, every 6 months for 5 years)
