HealthyNCT05117762
A Validation Study of Selfie Technology for Assessment of Vital Signs
An observational study of Healthy and Hypertension, run by DocMe Technologies Ltd at 1 site in United Kingdom.
Trial summary
The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hypertension
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2021to 31 Mar 2022
- Phase
- Observational
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study Population: We will seek to adhere to ISO (81060-2:2018)guidelines and AHA BP consensus standards. at least 5% population reference range systolic BP <100mmHg at least 5% population reference range systolic BP >160mmHg at least 20% population reference range systolic BP >140mmHg at least 5% population reference range diastolic BP <60mmHg at least 5% population reference range diastolic BP >100mmHg at least 20% population reference range diastolic BP >80mmHg
Who may be able to join
- Adults (18 - 100 years old). Participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford University Hospitals NHS Foundation
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: A Validation Study Comparing the Heart Rate, Respiratory Rate, Heart Rate Variability and Blood Pressure Obtained by Video Selfie Using DocMe® Technology With Those Obtained by Direct Measurement in Adults
The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.
Read the detailed description
Photoplethysmography (PPG) makes uses of low-intensity infrared (IR) light. When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light.
The signal from PPG is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. PPG is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits.
Recently, it has been shown that PPG data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this.
DocMe Health Technologies has developed a system of obtaining these data using a video selfie.
At this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. However, to make the technology more widely useful, the results obtained by video selfies need to be formally validated.
The aim of the study therefore is to compare measurements obtained from video selfies with measurements taken using already validated machines in the same patients.
- Conditions
- Healthy, Hypertension
- Keywords
- Photoplethysmography, Video Selfie, Vital Signs, Blood Pressure, Oxygen Saturation, Smartphone, DocMe, Heart Rate, Respiratory Rate
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion
Measured: Baseline
Respiratory Rate
Respiratory Rate in breaths/min assessed visually or oximeter if it has the capability assessed 3 times at 10 minute intervals on one occasion
Measured: Baseline
Heart Rate Variability
Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion
Measured: Baseline
Blood Pressure
Systolic and Diastolic Blood Pressure assessed 3 times at 10 minute intervals on one occasion
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start2 Nov 2021 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DocMe Technologies Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Alex T Novak, MRCGP FRCEM, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117762
- Sponsor's protocol ID
- PRFX-2020-01
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barszczyk A, Lee K. Measuring Blood Pressure: from Cuff to Smartphone. Curr Hypertens Rep. 2019 Oct 10;21(11):84. doi: 10.1007/s11906-019-0990-3.
PubMed 31599362Luo H, Yang D, Barszczyk A, Vempala N, Wei J, Wu SJ, Zheng PP, Fu G, Lee K, Feng ZP. Smartphone-Based Blood Pressure Measurement Using Transdermal Optical Imaging Technology. Circ Cardiovasc Imaging. 2019 Aug;12(8):e008857. doi: 10.1161/CIRCIMAGING.119.008857. Epub 2019 Aug 6.
PubMed 31382766Chowdhury MH, Shuzan MNI, Chowdhury MEH, Mahbub ZB, Uddin MM, Khandakar A, Reaz MBI. Estimating Blood Pressure from the Photoplethysmogram Signal and Demographic Features Using Machine Learning Techniques. Sensors (Basel). 2020 Jun 1;20(11):3127. doi: 10.3390/s20113127.
PubMed 32492902Humphreys K, Ward T, Markham C. Noncontact simultaneous dual wavelength photoplethysmography: a further step toward noncontact pulse oximetry. Rev Sci Instrum. 2007 Apr;78(4):044304. doi: 10.1063/1.2724789.
PubMed 17477684Kong L, Zhao Y, Dong L, Jian Y, Jin X, Li B, Feng Y, Liu M, Liu X, Wu H. Non-contact detection of oxygen saturation based on visible light imaging device using ambient light. Opt Express. 2013 Jul 29;21(15):17464-71. doi: 10.1364/OE.21.017464.
PubMed 23938616
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study Comparing the Heart Rate, Respiratory Rate, Heart Rate Variability and Blood Pressure Obtained by Video Selfie Using DocMe® Technology With Those Obtained by Direct Measurement in Adults
- ClinicalTrials.gov ID
- NCT05117762
- Acronym / sponsor ID
- PRFX-2020-01
- Conditions
- Healthy, Hypertension
- Keywords
- Photoplethysmography, Video Selfie, Vital Signs, Blood Pressure, Oxygen Saturation, Smartphone, DocMe, Heart Rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- DocMe Technologies LtdIndustry (pharma, biotech, devices)
- Collaborators
- Oxford University Hospitals NHS Trust
- Study start
- 2 Nov 2021 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 11 Nov 2021 (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.
The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.
Detailed description
Photoplethysmography (PPG) makes uses of low-intensity infrared (IR) light. When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light.
The signal from PPG is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. PPG is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits.
Recently, it has been shown that PPG data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this.
DocMe Health Technologies has developed a system of obtaining these data using a video selfie.
At this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. However, to make the technology more widely useful, the results obtained by video selfies need to be formally validated.
The aim of the study therefore is to compare measurements obtained from video selfies with measurements taken using already validated machines in the same patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study Population: We will seek to adhere to ISO (81060-2:2018)guidelines and AHA BP consensus standards. at least 5% population reference range systolic BP <100mmHg at least 5% population reference range systolic BP >160mmHg at least 20% population reference range systolic BP >140mmHg at least 5% population reference range diastolic BP <60mmHg at least 5% population reference range diastolic BP >100mmHg at least 20% population reference range diastolic BP >80mmHg
Key inclusion criteria (1 listed)
- Adults (18 - 100 years old). Participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Rate
Time frame: Baseline
Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion
Respiratory Rate
Time frame: Baseline
Respiratory Rate in breaths/min assessed visually or oximeter if it has the capability assessed 3 times at 10 minute intervals on one occasion
Heart Rate Variability
Time frame: Baseline
Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion
Blood Pressure
Time frame: Baseline
Systolic and Diastolic Blood Pressure assessed 3 times at 10 minute intervals on one occasion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Background: PubMed 31599362Barszczyk A, Lee K. Measuring Blood Pressure: from Cuff to Smartphone. Curr Hypertens Rep. 2019 Oct 10;21(11):84. doi: 10.1007/s11906-019-0990-3.
- Background: PubMed 31382766Luo H, Yang D, Barszczyk A, Vempala N, Wei J, Wu SJ, Zheng PP, Fu G, Lee K, Feng ZP. Smartphone-Based Blood Pressure Measurement Using Transdermal Optical Imaging Technology. Circ Cardiovasc Imaging. 2019 Aug;12(8):e008857. doi: 10.1161/CIRCIMAGING.119.008857. Epub 2019 Aug 6.
- Background: PubMed 32492902Chowdhury MH, Shuzan MNI, Chowdhury MEH, Mahbub ZB, Uddin MM, Khandakar A, Reaz MBI. Estimating Blood Pressure from the Photoplethysmogram Signal and Demographic Features Using Machine Learning Techniques. Sensors (Basel). 2020 Jun 1;20(11):3127. doi: 10.3390/s20113127.
- Background: PubMed 17477684Humphreys K, Ward T, Markham C. Noncontact simultaneous dual wavelength photoplethysmography: a further step toward noncontact pulse oximetry. Rev Sci Instrum. 2007 Apr;78(4):044304. doi: 10.1063/1.2724789.
- Background: PubMed 23938616Kong L, Zhao Y, Dong L, Jian Y, Jin X, Li B, Feng Y, Liu M, Liu X, Wu H. Non-contact detection of oxygen saturation based on visible light imaging device using ambient light. Opt Express. 2013 Jul 29;21(15):17464-71. doi: 10.1364/OE.21.017464.
- 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.
Alex T Novak, MRCGP FRCEM principal investigator
Oxford University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Hypertension, run by DocMe Technologies Ltd at 1 site in United Kingdom.
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 1 inclusion and 1 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 11 Nov 2021. 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 Kingdom. 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?
Heart Rate (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05117762, which also lists 5 linked publications.
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 11 Nov 2021.