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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04539860
Other study ID # 32755
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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