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

NCT ID: NCT04539860

Last Updated: 2020-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-25

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Blood Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Controls

Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging

Transdermal Optical Imaging

Intervention Type DEVICE

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

Patients

Blood pressure measurements by standard assessment methods and Transdermal Optical Imaging

Transdermal Optical Imaging

Intervention Type DEVICE

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

Interventions

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Transdermal Optical Imaging

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

13 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nuralogix Corporation

INDUSTRY

Sponsor Role collaborator

The Affiliated Hospital of Hangzhou Normal University

OTHER

Sponsor Role collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Kang Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kang Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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University of Toronto

Toronto, Ontario, Canada

Site Status RECRUITING

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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Canada China

Central Contacts

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Kang Lee, PhD

Role: CONTACT

416-934-4597

Si Jia Wu, MA

Role: CONTACT

Facility Contacts

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Si Jia Wu, MA

Role: primary

Xiaoping Gu, PhD

Role: primary

Deye Yang, MD

Role: primary

Other Identifiers

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32755

Identifier Type: -

Identifier Source: org_study_id

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