A Single Blind Randomized Study Comparing In-laboratory Polysomnography Electrocardiogram to Simultaneously Recorded In-laboratory Electrocardiogram on the CPC M1 Device and Compared to Home Recorded Electrocardiogram With the CPC M1 Device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.
研究概览
简要总结
Research study that will test a portable device (CPC M1) that records: body movement; heart activity (ECG; snoring; and body position during sleep. The Food and Drug Administration (FDA) has not approved this device for use except in a research setting.
The purposes of this study are to: a) determine if the ECG data collected using the CPC M1 device is at least as good as the ECG data collected during a diagnostic, in-lab polysomnogram (PSG) (or sleep study) and b) determine if in-home monitoring with the device will provide similar results compared to an in-lab PSG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (males and females) 18 to 70 years of age with a suspected sleep disorder.
- •Subjects or legal guardians are able to verbalize an understanding of the consent form, provide written informed consent, and verbalize willingness to complete study procedures.
- •Adequate dexterity to apply and remove the CPC M1 device.
排除标准
- •Patients with atrial fibrillation and ventricular tachycardia.
- •Patients with an inability to apply the CPC M1 device.
研究组 & 干预措施
ECG recording
In-laboratory vs. in-home recordings
干预措施: CPC M1 (Device)
结局指标
主要结局
Sensitivity and specificity of an electrocardiogram-based method to predict the presence of a sleep disorder.
时间窗: 6 months
Does the ECG-based data obtained from a portable device correlate to a similar analysis of simultaneously recorded ECG data obtained from standard polysomnography?
次要结局
未报告次要终点