Blood PressureNCT05196048
Blood Pressure Sensor of Watch-type Device With ECG Technology
An observational study of Blood Pressure, run by ASUSTek Computer INC. at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Sep 2021to 20 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
China Medical University Hsinchu Hospital
Hsinchu, No. 199, Sec. 1, Xinglong Rd., Zhubei City, 302056
Yeh-Peng Chen, MDPHD, 0928307070, b8201002@gmail.com
About this study
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.
- Conditions
- Blood Pressure
- Being tested
- No Intervention
- Keywords
- AI Algorithm, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No Intervention Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: 1 hour per individual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start21 Sep 2021
- Primary completion10 May 2022 (estimated)
- Study completion20 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ASUSTek Computer INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- China Medical University, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yeh-Pang Chen, MDPHD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196048
- Sponsor's protocol ID
- CMUH110-REC2-162
- Status last verified
- Sep 2021
- First submitted
- 5 Jan 2022
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Sensor of Watch-type Device With ECG Technology
- ClinicalTrials.gov ID
- NCT05196048
- Acronym / sponsor ID
- CMUH110-REC2-162
- Conditions
- Blood Pressure
- Keywords
- AI Algorithm, blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ASUSTek Computer INC.Industry (pharma, biotech, devices)
- Collaborators
- China Medical University, Taiwan
- Study start
- 21 Sep 2021 (actual)
- Primary completion
- 10 May 2022 (estimated)
- Study completion
- 20 Sep 2022 (estimated)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No Intervention | – | Other: No InterventionNo Intervention |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo Intervention | Other | No Intervention |
Primary outcome
Level of accordance between the ASUS HealthConnect App (Blood Pressure Monitor) and the sphygmomanometer
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeh-Pang Chen, MDPHD principal investigator
China Medical University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by ASUSTek Computer INC. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yeh-Pang Chen, MDPHD (0928307070, D8083@mail.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of accordance between the ASUS HealthConnect App (Blood Pressure Monitor) and the sphygmomanometer (time frame: 1 hour per individual). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.