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MediBeat - HeartBeat Observation Trial

NCT04082819 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2020-04-01

Study results available
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Summary

The goal of the study was to compare the current gold standard blood pressure instrument (a mercury-filled sphygmomanometer with cuff and stethoscope) with the new experimental algorithm developed by HeartBeat Technologies Ltd. To that end, participants were recruited from Markham, Ontario and participated in a series of alternating blood pressure measurements over a period of 45 minutes. Comparisons were made between manual measurements and device measurements to determine the quality of the device readings. Measurements were taken by trained nurses and staff were consistent across the study duration.

Conditions

Interventions

DEVICE

Contec CMS50EW

Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.

DEVICE

Sphygmomanometer

Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.

Sponsors & Collaborators

  • Centre for Aging and Brain Health Innovation

    collaborator OTHER

  • SE Health

    lead OTHER

Principal Investigators

  • Paul Holyoke, PhD · SE Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2019-11-22
Completion
2019-12-17
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04082819 on ClinicalTrials.gov