NCT05465018

Performance Assessment Study VitalSigns Camera

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Humans
• Vital Signs Monitoring

Interventions

Type	Name	Description
DEVICE	Happy Flow / Baseline	Baseline (without make-up or mask)
DEVICE	Make-up	To test device on participant who is wearing facial make-up
DEVICE	Sunglasses	To test device on participant who is wearing sunglasses
DEVICE	Face mask	To test device on participant who is wearing a facial mask
DEVICE	Minimum requirements camera	To test the minimum requirements of the camera
DEVICE	Worst case hardware	To test if software still works with an older smartphone
DEVICE	Damaged lens	To test if software is still working when the lens of the smartphone is damaged
DEVICE	Face or chest outside test frame	To test software if the participants face or chest is outside the test frame

Timeline

• Start date: 2022-07-07
• Primary completion: 2022-07-22
• Completion: 2022-09-30
• First posted: 2022-07-19
• Last updated: 2022-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study