Remote Photoplethysmography , Blood PressureNCT06320847
Predictive Remote Photoplethysmography Algorithm for Blood Pressure Pressure Assessment and Monitoring
A study testing rPPG in people with Remote Photoplethysmography , Blood Pressure, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Significant advancements in the field of medical technologies have resulted in the rise of contact-free methods of haemodynamic monitoring. Remote photoplethysmography (rPPG) is a videobased, contactless form of monitoring that operates through a camera-enabled device. Read more about this study
- Who is it for?
- Ages 21 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Remote Photoplethysmography , Blood Pressure
- What is being tested?
- rPPG
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Jan 2024to Dec 2024
- 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 21 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years old
- Ability to provide informed consent
- Any surgery except head and neck surgeries
Who cannot join
- Age ≤ 21 years old
- Inability to provide informed consent
- Patients going for head and neck surgery
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Hairil Rizal Abdullah, 63265428, hairil.rizal.abdullah@singhealth.com.sg
Hairil Rizal Abdullah
About this study
Official title: Development of Predictive Remote Photoplethysmography Algorithm for Blood Pressure Assessment and Monitoring
Significant advancements in the field of medical technologies have resulted in the rise of contact-free methods of haemodynamic monitoring. Remote photoplethysmography (rPPG) is a videobased, contactless form of monitoring that operates through a camera-enabled device. This innovation interprets minute variations in skin colour due to blood flow which, when analysed with complex signal processing algorithms, generates vital sign readings. Currently, Nervotec's rPPG technology allows for the collection of rPPG waveforms, which enables the measurement of heart rate, heart rate variability, respiration rate and blood oxygen saturation (SpO2) level through signal processing techniques. The plethysmography signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and BP can be studied.
Read the detailed description
This is a prospective, feasibility study.Background literature has shown that plethysmography (PPG) signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and blood pressure can be studied.
Nervotec, a digital health and AI company , has successfully used rPPG technology to allow for collection of rPPG waveforms, which enables the measurement of heart rate (HR), heart rate variability (HRV), respiration rate (RR) and blood oxygen saturation (SpO2) level through signal processing techniques. They have incorporated rPPG technology into a mobile application using smartphone cameras for scanning an individual's face. However, this is yet to be established for blood pressure. We aim to perform a prospective study to evaluate the feasibility and accuracy of obtaining blood pressure measurements through rPPG.
Hypothesis: Remote photoplethysmography can be used to determine blood pressure and this algorithm can develop into a customised smartphone based application.
- Being tested
- rPPG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPPGDiagnostic test
A pulse oximeter and blood pressure cuff will be applied on the study patient by the study team member (research coordinators). At the same time, vital signs from Nervotec's rPPG technology will be recorded via the laptop and webcam. Synchronous measurement process of heart rate, respiration rate, pulse oximetry, heart rate variability and blood pressure estimates using Nervotec rPPG technology will take place for a duration of 3 minutes.
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the correlation between remote photoplethysmography (rPPG) and blood pressure variations.
Measured: 1 year
To develop a predictive model in using rPPG for determination of blood pressure.
Measured: 1 year
To validate this predictive model by comparing blood pressure readings obtained using rPPG with standard procedures such as contact sensors and automated oscillometry.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start2 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remote Photoplethysmography , Blood PressureStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nervotec Pte. Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320847
- Sponsor's protocol ID
- Predictbloodpressure
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Predictive Remote Photoplethysmography Algorithm for Blood Pressure Assessment and Monitoring
- ClinicalTrials.gov ID
- NCT06320847
- Acronym / sponsor ID
- Predictbloodpressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Nervotec Pte. Ltd.
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Mar 2024 (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.
Significant advancements in the field of medical technologies have resulted in the rise of contact-free methods of haemodynamic monitoring. Remote photoplethysmography (rPPG) is a videobased, contactless form of monitoring that operates through a camera-enabled device. This innovation interprets minute variations in skin colour due to blood flow which, when analysed with complex signal processing algorithms, generates vital sign readings. Currently, Nervotec's rPPG technology allows for the collection of rPPG waveforms, which enables the measurement of heart rate, heart rate variability, respiration rate and blood oxygen saturation (SpO2) level through signal processing techniques. The plethysmography signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and BP can be studied.
Detailed description
This is a prospective, feasibility study.Background literature has shown that plethysmography (PPG) signals can be used to estimate blood pressure through the creation and training of a predictive model. By examining and extracting key features of a continuous PPG waveform by training an artificial neural network, correlations between these features and blood pressure can be studied.
Nervotec, a digital health and AI company , has successfully used rPPG technology to allow for collection of rPPG waveforms, which enables the measurement of heart rate (HR), heart rate variability (HRV), respiration rate (RR) and blood oxygen saturation (SpO2) level through signal processing techniques. They have incorporated rPPG technology into a mobile application using smartphone cameras for scanning an individual's face. However, this is yet to be established for blood pressure. We aim to perform a prospective study to evaluate the feasibility and accuracy of obtaining blood pressure measurements through rPPG.
Hypothesis: Remote photoplethysmography can be used to determine blood pressure and this algorithm can develop into a customised smartphone based application.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 21 years old
- Ability to provide informed consent
- Any surgery except head and neck surgeries
Key exclusion criteria (3 listed)
- Age ≤ 21 years old
- Inability to provide informed consent
- Patients going for head and neck surgery
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 |
|---|---|---|
| rPPGA pulse oximeter and blood pressure cuff will be applied on the study patient by the study team member (research coordinators). At the same time, vital signs from Nervotec's rPPG technology will be recorded via the laptop and webcam. Synchronous measurement process of heart rate, respiration rate, pulse oximetry, heart rate variability and blood pressure estimates using Nervotec rPPG technology will take place for a duration of 3 minutes. | Diagnostic test | – |
Primary outcome
To determine the correlation between remote photoplethysmography (rPPG) and blood pressure variations.
Time frame: 1 year
To develop a predictive model in using rPPG for determination of blood pressure.
Time frame: 1 year
To validate this predictive model by comparing blood pressure readings obtained using rPPG with standard procedures such as contact sensors and automated oscillometry.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rPPG in people with Remote Photoplethysmography , Blood Pressure, run by Singapore General Hospital at 1 site in Singapore.
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 3 inclusion and 3 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 20 Mar 2024. 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 Singapore. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the correlation between remote photoplethysmography (rPPG) and blood pressure variations. (time frame: 1 year). The study lists 3 primary outcomes in all. 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 20 Mar 2024.