Blood Pressure Sensor of Watch-type Device With ECG Technology

• Conditions: Blood Pressure
• Interventions: Other: No Intervention

• Registration Number: NCT05196048
• Lead Sponsor: ASUSTek Computer INC.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-21
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-05
• Last Update Submitted: 2022-01-05
• Study First Posted: 2022-01-19
• Last Update Posted: 2022-01-19
• Primary Completion: 2022-05-10
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No Intervention	No Intervention	No Intervention

Primary Outcome Measures

Name	Time	Method
Level of accordance between the ASUS HealthConnect App (Blood Pressure Monitor) and the sphygmomanometer	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.

Trial Locations

Locations (1)

China Medical University Hsinchu Hospital; 🇨🇳 Hsinchu, No. 199, Sec. 1, Xinglong Rd., Zhubei City, Taiwan