Performance Assessment Study VitalSigns Camera

Philips

Status: Active, not recruiting

Conditions: Healthy Humans; Vital Signs Monitoring

Treatments: Device: Make-up; Device: Sunglasses; Device: Minimum requirements camera; Device: Happy Flow / Baseline; Device: Damaged lens; Device: Worst case hardware; Device: Face or chest outside test frame; Device: Face mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT05465018

ICBE-S-000822

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Healthy volunteers

Experimental group

Description:

1 arm. Healthy volunteers assigned to different interventions

Treatment:

Device: Sunglasses

Device: Minimum requirements camera

Device: Make-up

Device: Happy Flow / Baseline

Device: Face or chest outside test frame

Device: Face mask

Device: Damaged lens

Device: Worst case hardware