Evaluation of EarlySense - a Contact-less Heart and Respiration Rate Monitor in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab
研究概览
简要总结
The study objective is to collect heart rate, respiration rate and motion data of patients admitted to sleep lab and to determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab (e.g., Polysomnography, respiratory belts, ECG, etc..) . Data regarding sleep condition, scoring and quality of sleep and in and out of bed status, patient turns will also be collected and compared to data collected by EarlySense contactless monitor. Different patient population will be monitored including obese, morbidly obese, patients with or without obstructive/central apnea, patients with or without arrhythmia as well as healthy population who arrive to sleep lab for general evaluation will be monitored
详细描述
EarlySense sensors will be placed under the mattress of subjects who have been included in the study. The sensors will not be in any contact with the patient. Two sensors will be utilized and placed under the subject's chest and pelvis area. Accuracy of the sensors will be compared to each other and to the reference device.
研究设计
- 研究类型
- Observational
- 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
- 是
入选标准
- •Age 18 years or above
- •Is willing to sign the consent form
排除标准
- •Age < 18 years
- •Is not willing to sign the consent form
结局指标
主要结局
To determine the accuracy level of the EarlySense system vs. the monitors used in sleep lab
时间窗: up to 12 hours
the measurements from the EarlySense System will be compared with the "Gold standard" equipment that is being used in the sleep Lab
次要结局
未报告次要终点