Performance Assessment Study VitalSigns Camera

Not Applicable

• Conditions: Healthy Humans; Vital Signs Monitoring
• Interventions: Device: Happy Flow / Baseline; Device: Make-up; Device: Sunglasses; Device: Face mask; Device: Minimum requirements camera; Device: Worst case hardware; Device: Damaged lens; Device: Face or chest outside test frame

• Registration Number: NCT05465018
• Lead Sponsor: Philips Clinical & Medical Affairs Global

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-07
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Primary Completion: 2022-07-22
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18
• Study Completion: 2022-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Make-up	1 arm. Healthy volunteers assigned to different interventions
Healthy volunteers	Worst case hardware	1 arm. Healthy volunteers assigned to different interventions
Healthy volunteers	Happy Flow / Baseline	1 arm. Healthy volunteers assigned to different interventions
Healthy volunteers	Sunglasses	1 arm. Healthy volunteers assigned to different interventions
Healthy volunteers	Face mask	1 arm. Healthy volunteers assigned to different interventions
Healthy volunteers	Minimum requirements camera	1 arm. Healthy volunteers assigned to different interventions
Healthy volunteers	Damaged lens	1 arm. Healthy volunteers assigned to different interventions
Healthy volunteers	Face or chest outside test frame	1 arm. Healthy volunteers assigned to different interventions

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Philips Research North America; 🇺🇸 Cambridge, Massachusetts, United States