Single-center Evaluation of Sleepiz One+ Algorithm in Estimating Respiration Rate and Heart Rate Compared to Gold Standard
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sleepiz AG
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Instantaneous respiration rate measurement accuracy per 60s epoch
研究概览
简要总结
Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors. Effective management of chronic diseases relies on detecting pathological changes early, with RR being among the most sensitive predictors of patient deterioration. Therefore, vigilant monitoring of RR and HR is vital for improving patient outcomes.
The primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ algorithms and end-tidal carbon dioxide measurement (EtCO2) Capnography for measuring respiration rate and electrocardiography (ECG) for measuring heart rate, in healthy adults and patients suffering from chronic conditions (e.g., hypertension, Chronic Obstructive Pulmonary Disease (COPD), asthma, diabetes), at rest in a clinical setting when the data is acquired with the new hardware version. Additionally, the investigators will evaluate the performance of RR estimation against the thoracic effort belt and the HR against the pulse oximetry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
研究组 & 干预措施
Sleepiz One+ vs. gold standard
Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed.
干预措施: Sleepiz One+ (Device)
结局指标
主要结局
Instantaneous respiration rate measurement accuracy per 60s epoch
时间窗: During 60 seconds
Instantaneous respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed
Instantaneous heart rate measurement accuracy per 60s epoch
时间窗: During 60 seconds
Instantaneous heart rate measurement accuracy per 60s epoch against ECG R-R interval, recorded on subjects lying down and resting on a bed
次要结局
未报告次要终点