Blood Pressure Sensor of Watch-type Device With ECG Technology

NCT ID: NCT05196048

Last Updated: 2022-01-19

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

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-21

Study Completion Date

2022-09-20

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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No Intervention

No Intervention

No Intervention

Intervention Type OTHER

No Intervention

Interventions

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No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

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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.

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
Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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China Medical University, Taiwan

OTHER

Sponsor Role collaborator

ASUSTek Computer INC.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yeh-Pang Chen, MDPHD

Role: PRINCIPAL_INVESTIGATOR

China Medical University Hospital

Locations

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China Medical University Hsinchu Hospital

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

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yeh-Pang Chen, MDPHD

Role: CONTACT

0928307070

Kuo-Hung Lin, MDPHD

Role: CONTACT

0422062121 ext. 3483

Facility Contacts

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Yeh-Peng Chen, MDPHD

Role: primary

0928307070

Other Identifiers

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CMUH110-REC2-162

Identifier Type: -

Identifier Source: org_study_id

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