Contactless Measurement of Heart Rate, Heart Rate Variability and Breathing Rate Using Face Video Analysis (Remote Photoplethysmography) - Validation of Shen.AI Vitals Software.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Accuracy of heart rate variability index (SDNN) measurement with the software under test compared with the ECG-based measurement
研究概览
简要总结
The purpose of this study it to evaluate the accuracy of heart rate, heart rate variability and breathing rate measurement with the use of Shen.AI Vitals software developed by MX Labs.
详细描述
Resting heart rate (HR), heart rate variability (HRV) and breathing rate (BR) will be measured (estimated) with the use of remote photoplethysmography (1-minute face video analysis with Shen.AI Vitals software).
The measurements will be taken with various camera-equipped devices (smartphones, tablets, laptops) using either front camera (self-measurement) or rear camera (measurement made by someone else), in two different lighting conditions (artificial light or natural daylight), with various levels of device stability (fully stable or held in hand/s), and in two different body positions (sitting or supine). In total, each participant will have 8 measurements taken.
Standard deviation of normal heartbeat intervals (SDNN) will be used as the main HRV index.
Apart from the average HR (averaged over the whole 1-minute measurement), instantaneous values of HR (averaged over 10 s) will also be determined and displayed every 1 s by the Shen.AI VItals software.
In all cases, reference measurements will be taken simultaneously (chest ECG for the calculation of average and instantaneous HR as well as HRV; impedance pneumography for the determination of BR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •ability to read and write in Polish or English
- •ability to operate a smartphone, tablet and laptop without the need for glasses
- •ability to understand the study procedure
- •ability to communicate and follow the instructions of the study staff
- •written consent to participate in the study and to the processing of personal data by the research team and the sponsor of the study
排除标准
- •failure to provide the required information in the participant's information survey
- •failure to comply with the study procedure or the instructions of the study stuff
- •extensive facial skin damage (including abrasions, wounds, burns)
- •a disease process involving a large part of the face that makes the video- based measurement impossible
- •extensive face dressing
- •extensive facial skin tattoo or face painting
- •marked deformation of the face (e.g. a tumor)
- •inability to keep the head stable in the required position during the measurement
- •persistent cough making it impossible to remain still during the measurement
- •respiratory dysfunction in the form of shortness of breath or irregular or shallow breathing
- •diagnosed arrhythmia (except sinus bradycardia or tachycardia)
- •moderate or severe anemia
- •diagnosed: heart failure, left ventricular systolic dysfunction, aortic stenosis or other diseases or disorders within the heart vascular system leading to decreased stroke volume, low pressure amplitude or the so-called paradoxical pulse
结局指标
主要结局
Accuracy of heart rate variability index (SDNN) measurement with the software under test compared with the ECG-based measurement
时间窗: day 1 (single visit, approximately 30 minutes)
In each participant, the standard deviation of normal heartbeat intervals (SDNN) will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using the Bland-Altman analysis.
Accuracy of breathing rate (BR) measurement with the software under test compared with the impedance pneumography-based measurement
时间窗: day 1 (single visit, approximately 30 minutes)
In each participant, the breathing rate will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded impedance pneumography signal. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using the Bland-Altman analysis.
Accuracy of instantaneous heart rate measurement with the software under test compared with the ECG-based measurement
时间窗: day 1 (single visit, approximately 30 minutes)
In each participant, multiple instantaneous heart rate values (averaged over 10 s) will be estimated from the software under test and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using non-parametric limits of agreement.
Accuracy of heart rate (HR) measurement with the software under test compared with the ECG-based measurement
时间窗: day 1 (single visit, approximately 30 minutes)
In each participant, average HR will be estimated from 1-minute video-based remote photoplethysmography of the facial skin (software under test) and calculated from simultaneously recorded ECG. Measurements will be made in resting conditions (seated position), with artificial lighting and a fully stabilized camera device. The results from both methods will be compared using non-parametric limits of agreement.
次要结局
- Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test on a smartphone held in hand/s (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held in hand/s (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of heart rate (HR) with the software under test in daylight conditions (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held by someone else (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test in daylight conditions (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of heart rate (HR) with the software under test on a smartphone held by someone else (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test on a smartphone held by someone else (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of breathing rate (BR) with the software under test on a smartphone held in hand/s (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Utility of the software under test for self-measurement of physiological parameters (assessed with a questionnaire).(day 1 (after a single visit, approximately 30 minutes))
- Utility of the software under test for the measurement of someone's physiological parameters (assessed with a questionnaire).(day 1 (after a single visit, approximately 30 minutes))
- Accuracy of measurement of breathing rate (BR) with the software under test in daylight conditions (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement breathing rate (BR) with the software under test in the supine position (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of heart rate (HR) with the software under test in the supine position (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))
- Accuracy of measurement of heart rate variability index (SDNN - the standard deviation of NN intervals) with the software under test in the supine position (compared with reference measurements).(day 1 (single visit, approximately 30 minutes))