Blood Pressure Sensor of Watch-type Device With ECG Technology

January 5, 2022 updated by: ASUSTek Computer INC.
The ASUS Blood Pressure App "ASUS HealthConnect" is a software-only mobile medical application. It is designed to be compatible with ASUS VivoWatch SP watches and mobile phones. Used together to create, record, store, and display blood pressure information. This application determines the systolic and diastolic blood pressure and pulse rate and provides numerical and historical graphs after calibration with the cuff-type upper arm blood pressure monitor. The above data is only captured when the user is resting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
    • No. 199, Sec. 1, Xinglong Rd., Zhubei City
      • Hsinchu, No. 199, Sec. 1, Xinglong Rd., Zhubei City, Taiwan, 302056
        • Recruiting
        • China Medical University Hsinchu Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From the preparation before the calibration to the completion of the case acceptance, each person will be tested for about 1 hour, and two research nurses will assist in completing the setting and calibration. In the official measurement, the electronic mercury sphygmomanometer, and ASUS HealthConnect with ASUS VivoWatch SP were used to perform alternate measurements for a total of three comparisons to understand the difference in accuracy between the ASUS HealthConnect, the reference sphygmomanometer.

Description

  1. Inclusion criteria:

    This plan excludes those under 22 years of age, pregnant, and severe cardiovascular and neurological diseases. It is estimated that about 120 subjects will be admitted and divided into three groups:

    (1.1) The first group-High Range: At least 17 subjects over 22 years old with systolic blood pressure exceeding 140mmHg and diastolic blood pressure exceeding 90mmHg.

    (1.2) The second group-Middle Range: at least 17 subjects over 22 years old with systolic blood pressure ranging from 110mmHg to 140mmHg and diastolic blood pressure ranging from 60mmHg to 90mmHg.

    (1.3) The third group-Low Range: at least 17 subjects over 22 years old with systolic blood pressure lower than 110mmHg and diastolic blood pressure lower than 60mmHg.

  2. Exclusion criteria:

(2.1) People younger than 22 years old. (2.2) pregnancy. (2.3) the following conditions:

  • Arrhythmia
  • Prior heart failure or heart attack
  • Peripheral vascular disease or compromised circulation
  • Valvular disease (diseases concerning the aortic valve)
  • Cardiomyopathy
  • Other known cardiovascular disease
  • End-stage Renal Disease (ESRD)
  • Diabetes
  • Neurological disorder (for example, tremors)
  • Clotting disorder or you are taking prescribed blood thinners
  • Tattoo(s) on the wrist where you will wear the ASUS VivoWatch SP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Intervention
Other: No Intervention
No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of accordance between the ASUS HealthConnect App (Blood Pressure Monitor) and the sphygmomanometer
Time Frame: 1 hour per individual

Excerpted from Regulation 5.2.4.1.2 Data analysis The sphygmomanometer-under-test shall meet the following two criteria.

a) Criterion 1

  1. The differences of the n individual paired determinations of the sphygmomanometer-under-test and of the observers' readings with the reference sphygmomanometer for all subjects, calculated separately for systolic blood pressure and diastolic blood pressure, shall: i) the mean value of the differences be within or equal to ±5,0 mmHg. ii) the standard deviation no greater than 8,0 mmHg(1,07 kPa). iii) the mean value of the differences and the standard deviation shall be calculated and expressed to at least 0,1 mmHg (0,01 kPa).
  2. The reference blood pressure value shall be the average of the observers' readings with the reference sphygmomanometer preceding and following the sphygmomanometerunder-test determination.
1 hour per individual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASUSTek Computer INC.

Collaborators

China Medical University, Taiwan

Investigators

  • Principal Investigator: Yeh-Pang Chen, MDPHD, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Anticipated)

May 10, 2022

Study Completion (Anticipated)

September 20, 2022

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

January 19, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMUH110-REC2-162

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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