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

Sponsor

University of Toronto (Other)

Overall Status

Recruiting

CT.gov ID

NCT04539860

Collaborator

Nuralogix Corporation (Industry), The Affiliated Hospital of Hangzhou Normal University (Other), The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)

15,000

Enrollment

Locations

11.2

Anticipated Duration (Months)

5000

Patients Per Site

446.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure	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 Design

Study Type:

Observational

Anticipated Enrollment :

15000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 25, 2020

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Blood Pressure Results [Single visit; up to one day]
Comparison of Transdermal Optical Imaging data and Standard assessment data

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Toronto	Toronto	Ontario	Canada	M5S 1A1
2	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China
3	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang	China

Sponsors and Collaborators

University of Toronto
Nuralogix Corporation
The Affiliated Hospital of Hangzhou Normal University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

Principal Investigator: Kang Lee, PhD, University of Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kang Lee, Professor, University of Toronto

ClinicalTrials.gov Identifier:

NCT04539860

Other Study ID Numbers:

32755

First Posted:

Sep 7, 2020

Last Update Posted:

Sep 7, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 7, 2020