Performance Assessment Study VitalSigns Camera

Healthy Humans Clinical Trial

Official title:

Performance Assessment Study VitalSigns Camera

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05465018
• Other study ID #: ICBE-S-000822
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 7, 2022
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2022
• Source: Philips Clinical & Medical Affairs Global
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: September 30, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Humans

Intervention

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

Locations

Country	Name	City	State
United States	Philips Research North America	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.