Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea
研究概览
简要总结
The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm Diagnostic Systems, Inc. which has many sensors inside in a "Band-Aid" like strip in order to see if it can help diagnose capabilities in individuals suspected of having obstructive sleep apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable, battery-powered, flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and records a number of physiological health related parameters such as ECG, heart rate, pulse synchronized oxygen saturation, temperature, respiratory rate, depth of respiration and motion/position. One advantage of this device over current home diagnostic systems is the capability for recording over several nights.
The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to gold standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated sleep study will help us to make these determinations. Subjects will wear the device, which is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects will go about their normal daily activities and return the device via mail once completed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults over age 18
- •Considered to be at high likelihood for sleep apnea and already scheduled for a formal sleep study.
排除标准
- •Congestive heart failure or other major medical illness that would complicate the diagnosis of OSA.
- •Psychological or social situation that would make the study difficult for the patient.
结局指标
主要结局
Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea
时间窗: 10 days
To compare multiple biometric parameters tracked by the MultiSenseTM to gold-standard monitoring in an accredited sleep lab using polysomnography.
次要结局
- Home monitoring(10 days)
研究者
Steven Steinhubl
Director, Digital Medicine
Scripps Translational Science Institute
