Blood PressureNCT04539860
Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care
An observational study of Blood Pressure, run by University of Toronto at 3 sites in 2 countries.
Trial summary
Participants (patients and volunteers) will be recruited to have their blood pressure measured by standard blood pressure assessment methods while having their face video recorded. Read more about this study
- Who is it for?
- Ages 13 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Transdermal Optical Imaging
- Type of treatment
- Medical device
- How many people
- 15,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 25 Aug 2020to Aug 2021
- 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 13 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Only individuals, of any sex, over the age of 13 will be included in the study.
Who may be able to join
- Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).
Who cannot join
- No exclusion criteria
Trial locations and contacts
3 sites in 2 countries.
Si Jia Wu, MA contact
3 sites in 2 countries
China2 sites, 2 recruiting
- Recruiting
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang
Deye Yang, MD, deyeyang@126.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Xiaoping Gu, PhD, xiaopinggu@nju.edu.cn
Canada1 site, 1 recruiting
- Recruiting
University of Toronto
Toronto, Ontario, M5S 1A1
Si Jia Wu, MA, sijia.wu@mail.utoronto.ca
About this study
Participants (patients and volunteers) will be recruited to have their blood pressure measured by standard blood pressure assessment methods while having their face video recorded. The data collected will help improve the blood pressure measurement accuracy of Transdermal Optical Imaging, which relies on machine learning to extract physiological information from videos recorded.
Read the detailed description
There are many ways to measure blood pressure (monitors, mercury sphygmomanometer, aneroid devices), with most relying on a cuff-inflation. Transdermal Optical Imaging measures blood pressure using a video captured by any conventional camera (e.g., those on a phone, tablet, laptop) and advanced machine learning algorithms.
The current study aims to improve the accuracy of Transdermal Optical Imaging algorithms for measuring blood pressure. The investigators will recruit participants (patients with medical problems and healthy volunteers) to have their blood pressure measured in various ways (e.g.,by registered nurses with sphygmomanometer and stethoscope, continuous blood pressure monitor, etc.). Further, participants will have their faces video-recorded intermittently between standard measurements or at the same time as standard measures.
- Conditions
- Blood Pressure
- Being tested
- Transdermal Optical Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Optical ImagingDevice
Blood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging Receives: Device: Transdermal Optical Imaging | |
| Patients | Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging Receives: Device: Transdermal Optical Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Results
Comparison of Transdermal Optical Imaging data and Standard assessment data
Measured: Single visit; up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start25 Aug 2020
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Nuralogix Corporation, The Affiliated Hospital of Hangzhou Normal University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Responsible party
- Principal investigator, Kang Lee, University of Toronto
- Investigators
- Kang Lee, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539860
- Sponsor's protocol ID
- 32755
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 7 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared with other researchers outside the team of researchers involved in the current study. Findings of the study based on group results will be shared in publications.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care
- ClinicalTrials.gov ID
- NCT04539860
- Acronym / sponsor ID
- 32755
- Conditions
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Nuralogix Corporation, The Affiliated Hospital of Hangzhou Normal University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 7 Sep 2020 (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.
Participants (patients and volunteers) will be recruited to have their blood pressure measured by standard blood pressure assessment methods while having their face video recorded. The data collected will help improve the blood pressure measurement accuracy of Transdermal Optical Imaging, which relies on machine learning to extract physiological information from videos recorded.
Detailed description
There are many ways to measure blood pressure (monitors, mercury sphygmomanometer, aneroid devices), with most relying on a cuff-inflation. Transdermal Optical Imaging measures blood pressure using a video captured by any conventional camera (e.g., those on a phone, tablet, laptop) and advanced machine learning algorithms.
The current study aims to improve the accuracy of Transdermal Optical Imaging algorithms for measuring blood pressure. The investigators will recruit participants (patients with medical problems and healthy volunteers) to have their blood pressure measured in various ways (e.g.,by registered nurses with sphygmomanometer and stethoscope, continuous blood pressure monitor, etc.). Further, participants will have their faces video-recorded intermittently between standard measurements or at the same time as standard measures.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | – | Device: Transdermal Optical ImagingBlood pressure measurements by standard assessment methods and Transdermal Optical Imaging |
| Patients | – | Device: Transdermal Optical ImagingBlood pressure measurements by standard assessment methods and Transdermal Optical Imaging |
Who may qualify
- Ages
- 13 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Only individuals, of any sex, over the age of 13 will be included in the study.
Key inclusion criteria (1 listed)
- Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).
Key exclusion criteria (1 listed)
- No 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 |
|---|---|---|
| Transdermal Optical ImagingBlood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging | Device | Healthy Controls, Patients |
Primary outcome
Blood Pressure Results
Time frame: Single visit; up to one day
Comparison of Transdermal Optical Imaging data and Standard assessment data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Individual participant dataSharing planned: No. No IPD will be shared with other researchers outside the team of researchers involved in the current study. Findings of the study based on group results will be shared in publications.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
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.
Si Jia Wu, MA contact
Kang Lee, PhD principal investigator
University of Toronto
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by University of Toronto at 3 sites in 2 countries.
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 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Canada. 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?
Contact Kang Lee, PhD (416-934-4597, kang.lee@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure Results (time frame: Single visit; up to one day). 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 7 Sep 2020.