Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sleepiz AG
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed.
研究概览
简要总结
EtCO2, or exhaled carbon dioxide, is a non-invasive and commonly used measure for respiratory rate and function. It can be easily monitored using a device called a capnograph, which consists of a sensor that is placed near the patient's mouth or nose and a monitor that displays the concentration of carbon dioxide in the respiratory gases in real-time.
EtCO2 capnography is generally considered a reliable and accurate method for monitoring respiration and is often used as a gold standard for comparing the performance of other methods for measuring respiration.
Therefore, the primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ and EtCO2 Capnography for measuring respiration rate, in healthy adults and patients suffering from chronic conditions (e.g. hypertension, COPD, asthma, diabetes), at rest in a clinical setting. Additionally, the performance of heart rate estimation will be evaluated against ECG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Annotators of capnography data were blinded to the values provided by the investigational device
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 >=18years
- •Informed Consent as documented by signature
- •One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)
- •Healthy volunteers
- •Age >=18years
- •Informed Consent as documented by signature
- •No diagnosed chronic medical condition
排除标准
- •Previous enrolment into the current study,
- •Cardiac pacemaker or another implanted electrical device
- •Women who are pregnant or breastfeeding
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant
- •Healthy volunteers:
- •Previous enrolment into the current study,
- •Cardiac pacemaker or another implanted electrical device
- •Women who are pregnant or breastfeeding
- •Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant
- •Presence of diagnosed chronic medical condition
结局指标
主要结局
Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed.
时间窗: 60s
次要结局
未报告次要终点