Comparison of Blood Pressure Measurements Between Transdermal Optical Imaging and Standard of Care

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.

Study Overview

• Status: Unknown
• Conditions: Blood Pressure
• Intervention / Treatment: Device: Transdermal Optical Imaging

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 Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5S 1A1
      • Recruiting
      • University of Toronto
      • Contact: Si Jia Wu, MA; Email: sijia.wu@mail.utoronto.ca
• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Nanjing Drum Tower Hospital
      • Contact: Xiaoping Gu, PhD; Email: xiaopinggu@nju.edu.cn
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The affiliated hospital of Hangzhou Normal University
      • Contact: Deye Yang, MD; Email: deyeyang@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 96 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Controls; Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging	Device: Transdermal Optical Imaging; Blood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging
Patients; Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging	Device: Transdermal Optical Imaging; Blood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Results	Comparison of Transdermal Optical Imaging data and Standard assessment data	Single visit; up to one day

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The Affiliated Hospital of Hangzhou Normal University; Nuralogix Corporation
• Investigators: Principal Investigator: Kang Lee, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 32755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No