NCT05465018

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

15 days

First QC Date

July 15, 2022

Last Update Submit

August 16, 2022

Conditions

Healthy HumansVital Signs Monitoring

Keywords

Pulse rateRemote PhotoplethysmographyAlgorithms

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

1 arm. Healthy volunteers assigned to different interventions

Device: Happy Flow / BaselineDevice: Make-upDevice: SunglassesDevice: Face maskDevice: Minimum requirements cameraDevice: Worst case hardwareDevice: Damaged lensDevice: Face or chest outside test frame

Interventions

Happy Flow / BaselineDEVICE

Baseline (without make-up or mask)

Healthy volunteers
Make-upDEVICE

To test device on participant who is wearing facial make-up

Healthy volunteers
SunglassesDEVICE

To test device on participant who is wearing sunglasses

Healthy volunteers
Face maskDEVICE

To test device on participant who is wearing a facial mask

Healthy volunteers
Minimum requirements cameraDEVICE

To test the minimum requirements of the camera

Healthy volunteers
Worst case hardwareDEVICE

To test if software still works with an older smartphone

Healthy volunteers
Damaged lensDEVICE

To test if software is still working when the lens of the smartphone is damaged

Healthy volunteers
Face or chest outside test frameDEVICE

To test software if the participants face or chest is outside the test frame

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals who are not able to read and understand the English language
  • Known allergic reaction to facial make-up
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Philips Research North America

Cambridge, Massachusetts, 02141, United States

Location

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 19, 2022

Study Start

July 7, 2022

Primary Completion

July 22, 2022

Study Completion

September 30, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)