Healthy Humans, Vital Signs Monitoring
Conditions
Keywords
Pulse rate, Remote Photoplethysmography, Algorithms
Brief summary
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.
Interventions
DEVICEHappy Flow / Baseline
Baseline (without make-up or mask)
DEVICEMake-up
To test device on participant who is wearing facial make-up
DEVICESunglasses
To test device on participant who is wearing sunglasses
DEVICEFace mask
To test device on participant who is wearing a facial mask
DEVICEMinimum requirements camera
To test the minimum requirements of the camera
DEVICEWorst case hardware
To test if software still works with an older smartphone
DEVICEDamaged lens
To test if software is still working when the lens of the smartphone is damaged
DEVICEFace or chest outside test frame
To test software if the participants face or chest is outside the test frame
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* Individuals who are not able to read and understand the English language * Known allergic reaction to facial make-up * COVID-19
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint | 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. |
Countries
United States
Outcome results
None listed