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MediBeat - HeartBeat Observation Trial

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ClinicalTrials.gov Identifier: NCT04082819
Recruitment Status : Completed
First Posted : September 9, 2019
Results First Posted : April 1, 2020
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Centre for Aging and Brain Health Innovation
Information provided by (Responsible Party):
SE Health

Brief 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.

Condition or disease Intervention/treatment Phase
Low Blood Pressure Blood Pressure High Blood Pressure Hypertension Hypotension Device: Contec CMS50EW Device: Sphygmomanometer Not Applicable

Detailed Description:

The gold standard instrument for blood pressure measurement is a mercury-filled sphygmomanometer with cuff and stethoscope (Canadian Agency for Drugs and Technologies in Health; Canadian Electronic Library, 2012). However, such a device is not the most convenient for client self-monitoring or virtual (remote) care. Thus, there is a desire for an accurate, reliable alternative for the traditional mercury-containing sphygmomanometer.

HeartBeat Technologies Ltd. ("Heartbeat") has developed a novel approach to measuring blood pressure after an initial blood pressure reading using the conventional measurement method, supplemented by specific characteristics of a person (age, gender, height, weight, and heart rate), has established a "baseline measurement" for the person. The "novel approach" uses a finger pulse oximeter, the Contec CMS50EW device (Figure 1) (manufactured by Contec Medical Systems Co., Ltd., Shanghai, People's Republic of China). The finger pulse oximeter detects the changes in blood volume directly below the person's skin and indirectly measures oxygen saturation in the blood. The measurement is in the form of a photoplethysmogram (PPG) which is captured by the Contec oximeter and then, by Bluetooth technology, transmitted to a smartphone or tablet. A HeartBeat application, called MediBeat, on the smartphone or tablet then transmits the PPG to a server where a proprietary algorithm analyzes the baseline measurement for the person and the PPG to calculate the person's current blood pressure.

Heartbeat's intent is that the current blood pressure reading would then be made available to both the client and the health provider through separate web-based interfaces. Providers would be able to log onto the HeartBeat web-based application from anywhere to review and monitor the blood pressure of multiple clients, while clients can log onto the application to track their own measurements.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure
Actual Study Start Date : October 4, 2019
Actual Primary Completion Date : November 22, 2019
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Low Blood Pressure
Low blood pressure (systolic: 0-129, diastolic: 0-79)
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.

Medium Blood Pressure
Medium blood pressure (systolic: 130-160, diastolic: 80-100)
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.

High Blood Pressure
High blood pressure (systolic: 161 or higher, diastolic: 101 or higher)
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.




Primary Outcome Measures :
  1. Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings [ Time Frame: 45 - 60 minutes ]
    Each device reading was compared to the manual blood pressure reading taken before (R1) and after it (R2). The degree of alignment for systolic blood pressure was calculated by taking the difference between the two scores (manual and device). The reading with the best alignment was used.

  2. Difference Between Diastolic Manual and Device Blood Pressure Readings [ Time Frame: 45-60 minutes ]
    Each device reading was compared to the manual reading before (R1) and after (R2) it, to calculate the degree of alignment. The difference of the device and R1, and the device and R2 were taken. The smaller number was used for results reporting.



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult over 25 years of age

Exclusion Criteria:

  • those who have heart arrhythmias,
  • atrial fibrillations or atrial flutters,
  • an inaudible Korotkoff sound,
  • wounds of the upper arms/wrists, missing fingers, and/or
  • an arm circumference of more than 55 cm will be excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082819


Locations
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Canada, Ontario
SE Health
Markham, Ontario, Canada, L3R 6H3
Sponsors and Collaborators
SE Health
Centre for Aging and Brain Health Innovation
Investigators
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Principal Investigator: Paul Holyoke, PhD SE Health
  Study Documents (Full-Text)

Documents provided by SE Health:
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Responsible Party: SE Health
ClinicalTrials.gov Identifier: NCT04082819    
Other Study ID Numbers: MCD307-007-1920
First Posted: September 9, 2019    Key Record Dates
Results First Posted: April 1, 2020
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hypertension
Hypotension
Vascular Diseases
Cardiovascular Diseases