Blood Pressure Sensor of Watch-type Device With ECG Technology

Study Overview
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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.

Official Title
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Blood Pressure Sensor of Watch-type Device With ECG Technology

Conditions
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Blood Pressure

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention<br>No Intervention | Other: No Intervention<br>* No Intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AI Algorithm, blood pressure