NCT05196048

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
Last Updated

January 19, 2022

Status Verified

September 1, 2021

Enrollment Period

8 months

First QC Date

January 5, 2022

Last Update Submit

January 5, 2022

Conditions

Blood Pressure

Keywords

AI Algorithm, blood pressure

Outcome Measures

Primary Outcomes (1)

  • Level of accordance between the ASUS HealthConnect App (Blood Pressure Monitor) and the sphygmomanometer

    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

Study Arms (1)

No Intervention

No Intervention

Other: No Intervention

Interventions

No InterventionOTHER

No Intervention

No Intervention

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hsinchu Hospital

Hsinchu, No. 199, Sec. 1, Xinglong Rd., Zhubei City, 302056, Taiwan

RECRUITING

Study Officials

  • Yeh-Pang Chen, MDPHD

    China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeh-Pang Chen, MDPHD

CONTACT

0928307070D8083@mail.cmuh.org.tw

Kuo-Hung Lin, MDPHD

CONTACT

0422062121D13085@mail.cmuh.org.tw

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 19, 2022

Study Start

September 21, 2021

Primary Completion

May 10, 2022

Study Completion

September 20, 2022

Last Updated

January 19, 2022

Record last verified: 2021-09

Locations

TW(1)