Blood Pressure Sensor of Watch-type Device With ECG Technology

Blood Pressure Clinical Trial

Official title:

Blood Pressure Sensor of Watch-type Device With ECG Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05196048
• Other study ID #: CMUH110-REC2-162
• Status: Recruiting
• Start date: September 21, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: September 2021
• Source: ASUSTek Computer INC.
• Contact: Yeh-Pang Chen, MDPHD
• Phone: 0928307070
• Email: D8083[@]mail.cmuh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 20, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
Taiwan	China Medical University Hsinchu Hospital	Hsinchu	No. 199, Sec. 1, Xinglong Rd., Zhubei City

Sponsors (2)

Lead Sponsor	Collaborator
ASUSTek Computer INC.	China Medical University, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; 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).; 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