Performance Assessment Study VitalSigns Camera
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary endpoint
研究概览
简要总结
This Performance Assessment Study will focus on testing the performance of the VitalSigns Camera under various suboptimal use cases. The software makes it possible to measure the pulse rate (PR) and respiration rate (RR) without the device being in contact with the subject. The software delivers fast and accurate results (in less than one minute). Vital signs camera (VSC) product will be used via a demonstrator app on one of the smartphones during the study sessions (camera of the phone will be used by the VSC product). Devices will be provided by the researchers.
The subject will be asked to perform a number of assignments with the software application. The study involves taking a number of measurements of the subject's PR using the VitalSigns Camera software application (which is installed on a smartphone or laptop). In this study only PR is measured and not RR as the latter parameter is not affected by the designed test cases. The total duration of the session will be approximately 1 hour. In total, approximately 30 healthy volunteers will participate in this study.
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
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
- •Healthy volunteer must 18 years or older
- •Participants willing to give informed consent
- •Willingness to have vital signs measured by a medical mobile application
- •Willingness to put on sunglasses
- •Willingness to put on facial makeup
- •Willingness to put on a face mask covering mouth and nose
- •Willingness to sit still up to 2 minutes per measurement
排除标准
- •Individuals who are not able to read and understand the English language
- •Known allergic reaction to facial make-up
- •COVID-19 exclusion criteria:
- •Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing
- •Having been positively tested as infected with COVID-19 in the past 14 days
- •Travelled to or from high risk COVID-19 areas in the past 14 days
- •Been in contact with a (suspected) COVID-infected person in the past 14 days
研究组 & 干预措施
Healthy volunteers
1 arm. Healthy volunteers assigned to different interventions
干预措施: Minimum requirements camera (Device)
Healthy volunteers
1 arm. Healthy volunteers assigned to different interventions
干预措施: Worst case hardware (Device)
Healthy volunteers
1 arm. Healthy volunteers assigned to different interventions
干预措施: Face mask (Device)
Healthy volunteers
1 arm. Healthy volunteers assigned to different interventions
干预措施: Happy Flow / Baseline (Device)
Healthy volunteers
1 arm. Healthy volunteers assigned to different interventions
干预措施: Make-up (Device)
Healthy volunteers
1 arm. Healthy volunteers assigned to different interventions
干预措施: Sunglasses (Device)
Healthy volunteers
1 arm. Healthy volunteers assigned to different interventions
干预措施: Damaged lens (Device)
Healthy volunteers
1 arm. Healthy volunteers assigned to different interventions
干预措施: Face or chest outside test frame (Device)
结局指标
主要结局
Primary endpoint
时间窗: Each participants will have measurement for 1 hour on 1 day. Study will be completed within 1 week.
To compare the Pulse Rate (Beats per Minute) measured by the VitalSigns Camera with the Pulse Rate measured by the reference device.
次要结局
未报告次要终点