NCT04539860

Brief 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. 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 25, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

September 7, 2020

Status Verified

September 1, 2020

Enrollment Period

11 months

First QC Date

September 1, 2020

Last Update Submit

September 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure Results

    Comparison of Transdermal Optical Imaging data and Standard assessment data

    Single visit; up to one day

Study Arms (2)

Healthy Controls

Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging

Device: Transdermal Optical Imaging

Patients

Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging

Device: Transdermal Optical Imaging

Interventions

Blood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging

Healthy ControlsPatients

Eligibility Criteria

Age13 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Only individuals, of any sex, over the age of 13 will be included in the study.

You may qualify if:

  • Able and willing to provide written informed consent to participate (including by parent or legal guardian if under 16 years old).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Toronto

Toronto, Ontario, M5S 1A1, Canada

RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

RECRUITING

Study Officials

  • Kang Lee, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Si Jia Wu, MA

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 7, 2020

Study Start

August 25, 2020

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

September 7, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

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.

Locations