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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539860
• Other study ID #: 32755
• Status: Recruiting
• Start date: August 25, 2020
• Est. completion date: August 2021

Study information

• Verified date: September 2020
• Source: University of Toronto
• Contact: Kang Lee, PhD
• Phone: 416-934-4597
• Email: kang.lee[@]utoronto.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (4)

Lead Sponsor	Collaborator
University of Toronto	Nuralogix Corporation, The Affiliated Hospital of Hangzhou Normal University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Countries where clinical trial is conducted

Canada,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Pressure Results	Comparison of Transdermal Optical Imaging data and Standard assessment data	Single visit; up to one day