Prevalence of Sleep Disordered Breathing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site.
研究概览
简要总结
A novel technique in identifying unspecified sleep apnea has been developed. This technique uses signals typical acquired from a bedside monitor that is found in critical care environments. Those signals are then processed by a sleep analysis algorithm to provide an Apnoea Hypopnea Index (AHI) score. This study is intended to determine whether the prevalence of sleep disordered breathing identification among patients in a Coronary Care Unit (CCU) using this novel approach is significantly different than using routine techniques.
详细描述
This study will focus on inpatients diagnosed with coronary conditions. Specific eligibility criteria will include:
- Unstable angina
- Acute myocardial infarction
- Congestive heart failure Subjects enrolled in the study will be scored for sleep apnea using a novel approach designed by the sponsor. That score will not be used in the course of treatment. A follow-up call will determine whether the subject was identified for sleep disordered breathing during the hospital stay. A comparison will be done on the number of those identified with and without the use of the sleep scoring device.
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
- •Age equal to or greater than 18 years at time of consent
- •Written informed consent
- •Patients admitted to the intensive care unit if able to remove oxygen
- •Patients admitted to telemetry and step-down floor that will not require oxygen
- •Primary diagnosis (any of the following)
- •Un-stable angina
- •Acute myocardial infarction
- •Congestive heart failure
排除标准
- •Previously diagnosed sleep disordered breathing
- •Inability to consent
- •Pregnancy
- •Intubation (no longer excluded after extubation)
- •Oxygen therapy (no longer excluded after therapy ends)
- •End-Stage renal disease
- •End-Stage liver disease
- •Terminal disorders other than cardiac
- •Severe scoliosis
- •Cervical spinal cord injuries
- •Neuromuscular disorders
- •Severe COPD as defined by prescription of home oxygen therapy
- •Other unsuitable circumstances
结局指标
主要结局
Sleep disordered breathing was detected either by signals obtained from patient monitoring or by standard approaches by the site.
时间窗: 3 months
次要结局
- Length of CCU stay(3 months)
- Length of hospital stay(3 months)
- Prevalence of various sleep variables and correlation to known clinical and laboratory prognostic parameters(3 months)