Performance Assessment Study VitalSigns Camera

Sponsor

Philips Clinical & Medical Affairs Global (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05465018

Collaborator

(none)

Enrollment

Location

Arm

2.8

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Humans Vital Signs Monitoring	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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Performance Assessment Study VitalSigns Camera

Actual Study Start Date :

Jul 7, 2022

Actual Primary Completion Date :

Jul 22, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Philips Research North America	Cambridge	Massachusetts	United States	02141

Sponsors and Collaborators

Philips Clinical & Medical Affairs Global

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Philips Clinical & Medical Affairs Global

ClinicalTrials.gov Identifier:

NCT05465018

Other Study ID Numbers:

ICBE-S-000822

First Posted:

Jul 19, 2022

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Philips Clinical & Medical Affairs Global

Pulse rate

Remote Photoplethysmography

Algorithms

Study Results

No Results Posted as of Aug 18, 2022