Healthy HumansNCT05465018
Performance Assessment Study VitalSigns Camera
A study testing Happy Flow / Baseline, Make-up and Sunglasses in people with Healthy Humans and Vital Signs Monitoring, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Humans, Vital Signs Monitoring
- What is being tested?
- Happy Flow / Baseline, Make-up and Sunglasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Philips Research North America
Cambridge, Massachusetts, 02141
About this study
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.
- Conditions
- Healthy Humans, Vital Signs Monitoring
- Being tested
- Happy Flow / Baseline, Make-up, Sunglasses, Face mask, Minimum requirements camera
- Keywords
- Pulse rate, Remote Photoplethysmography, Algorithms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happy Flow / BaselineDevice
Baseline (without make-up or mask)
Make-upDevice
To test device on participant who is wearing facial make-up
SunglassesDevice
To test device on participant who is wearing sunglasses
Face maskDevice
To test device on participant who is wearing a facial mask
Minimum requirements cameraDevice
To test the minimum requirements of the camera
Worst case hardwareDevice
To test if software still works with an older smartphone
Damaged lensDevice
To test if software is still working when the lens of the smartphone is damaged
Face or chest outside test frameDevice
To test software if the participants face or chest is outside the test frame
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | 1 arm. Healthy volunteers assigned to different interventions Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
To compare the Pulse Rate (Beats per Minute) measured by the VitalSigns Camera with the Pulse Rate measured by the reference device.
Measured: Each participants will have measurement for 1 hour on 1 day. Study will be completed within 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start7 Jul 2022
- Primary completion22 Jul 2022
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy HumansStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465018
- Sponsor's protocol ID
- ICBE-S-000822
- Status last verified
- Aug 2022
- First submitted
- 15 Jul 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Assessment Study VitalSigns Camera
- ClinicalTrials.gov ID
- NCT05465018
- Acronym / sponsor ID
- ICBE-S-000822
- Conditions
- Healthy Humans, Vital Signs Monitoring
- Keywords
- Pulse rate, Remote Photoplethysmography, Algorithms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | 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 frame1 arm. Healthy volunteers assigned to different interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Individuals who are not able to read and understand the English language
- Known allergic reaction to facial make-up
- COVID-19 exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Happy Flow / BaselineBaseline (without make-up or mask) | Device | Healthy volunteers |
| Make-upTo test device on participant who is wearing facial make-up | Device | Healthy volunteers |
| SunglassesTo test device on participant who is wearing sunglasses | Device | Healthy volunteers |
| Face maskTo test device on participant who is wearing a facial mask | Device | Healthy volunteers |
| Minimum requirements cameraTo test the minimum requirements of the camera | Device | Healthy volunteers |
| Worst case hardwareTo test if software still works with an older smartphone | Device | Healthy volunteers |
| Damaged lensTo test if software is still working when the lens of the smartphone is damaged | Device | Healthy volunteers |
| Face or chest outside test frameTo test software if the participants face or chest is outside the test frame | Device | Healthy volunteers |
Primary outcome
Primary endpoint
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happy Flow / Baseline, Make-up and Sunglasses in people with Healthy Humans and Vital Signs Monitoring, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: Each participants will have measurement for 1 hour on 1 day. Study will be completed within 1 week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2022.