Performance Assessment Study VitalSigns Camera

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Humans; Vital Signs Monitoring
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02141
      • Philips Research North America

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy volunteers; 1 arm. Healthy volunteers assigned to different interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint	To compare the Pulse Rate (Beats per Minute) measured by the VitalSigns Camera with the Pulse Rate measured by the reference device.	Each participants will have measurement for 1 hour on 1 day. Study will be completed within 1 week.

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): July 22, 2022
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Algorithms; Pulse rate; Remote Photoplethysmography
• Other Study ID Numbers: ICBE-S-000822

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No