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

• Conditions: Blood Pressure
• Interventions: Device: Transdermal Optical Imaging

• Registration Number: NCT04539860
• Lead Sponsor: University of Toronto

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.

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 Timeline

• Study Start: 2020-08-25
• Status Verified: 2020-09
• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Last Update Submitted: 2020-09-01
• Study First Posted: 2020-09-07
• Last Update Posted: 2020-09-07
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Transdermal Optical Imaging	Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging
Healthy Controls	Transdermal Optical Imaging	Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging

Primary Outcome Measures

Name	Time	Method
Blood Pressure Results	Single visit; up to one day	Comparison of Transdermal Optical Imaging data and Standard assessment data

Trial Locations

Locations (3)

The Affiliated Hospital of Hangzhou Normal University; 🇨🇳 Hangzhou, Zhejiang, China

University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China