Performance Assessment Study VitalSigns Camera

NCT ID: NCT05465018

Last Updated: 2022-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-07

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Humans Vital Signs Monitoring

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

1 arm. Healthy volunteers assigned to different interventions

Group Type EXPERIMENTAL

Happy Flow / Baseline

Intervention Type DEVICE

Baseline (without make-up or mask)

Make-up

Intervention Type DEVICE

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

Sunglasses

Intervention Type DEVICE

To test device on participant who is wearing sunglasses

Face mask

Intervention Type DEVICE

To test device on participant who is wearing a facial mask

Minimum requirements camera

Intervention Type DEVICE

To test the minimum requirements of the camera

Worst case hardware

Intervention Type DEVICE

To test if software still works with an older smartphone

Damaged lens

Intervention Type DEVICE

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

Face or chest outside test frame

Intervention Type DEVICE

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

Interventions

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Happy Flow / Baseline

Baseline (without make-up or mask)

Intervention Type DEVICE

Make-up

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

Intervention Type DEVICE

Sunglasses

To test device on participant who is wearing sunglasses

Intervention Type DEVICE

Face mask

To test device on participant who is wearing a facial mask

Intervention Type DEVICE

Minimum requirements camera

To test the minimum requirements of the camera

Intervention Type DEVICE

Worst case hardware

To test if software still works with an older smartphone

Intervention Type DEVICE

Damaged lens

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

Intervention Type DEVICE

Face or chest outside test frame

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

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Philips Research North America

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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ICBE-S-000822

Identifier Type: -

Identifier Source: org_study_id

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