Clinical trial NCT05196048: Blood Pressure Sensor of Watch-type Device With ECG Technology
Official title: Blood Pressure Sensor of Watch-type Device With ECG Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Keywords: AI Algorithm, blood pressure
Lead sponsor: ASUSTek Computer INC.
Sponsor class: INDUSTRY
Collaborators: name: China Medical University, Taiwan
First posted: 2022-01-19
Enrollment: 120
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Level of accordance between the ASUS HealthConnect App (Blood Pressure Monitor) and the sphygmomanometer
timeFrame: 1 hour per individual
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: China Medical University Hsinchu Hospital
state: No. 199, Sec. 1, Xinglong Rd., Zhubei City
Study officials:
affiliation: China Medical University Hospital
name: Yeh-Pang Chen, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: