HypertensionHuawei-SunU2NCT07790978
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
An observational study of Hypertension, run by Sunway University at 1 site in Malaysia.
Trial summary
Background: Ambulatory Blood Pressure Monitoring (ABPM) is the gold standard for diagnosing high blood pressure (hypertension) because it tracks blood pressure continuously across day and night. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 500 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Dec 2026to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population comprises adult community-dwelling individuals residing in Malaysia recruited via the Huawei Research Platform. From this general screening pool (target N = 500), a targeted clinical validation subgroup (n = 50) will be prospectively selected to undergo dual ABPM and smartwatch evaluation. To ensure clinical applicability and statistical validity in alignment with ISO 81060-2 and AAMI validation standards, the validation subgroup will be stratified into three distinct cohorts: * Normotensive Cohort (n = 10): Participants with blood pressure < 135/85 mmHg. * Undiagnosed Elevated Blood Pressure Cohort (n = 20): Participants with untreated blood pressure > 135/85 mmHg. * Documented Hypertensive Cohort (n = 20): Participants with documented or self-reported history of history of hypertension. Selection across all cohorts will maintain balanced demographic representation across age groups, biological sex, and major Malaysian ethnic populations (Malay, Chinese, Indian)
Who may be able to join
- Possesses the specific Huawei wearable required for the study
- Aged ≥18 years
- Malaysian citizen/permanent resident
- Understands English, Malay, or Chinese
- Able to download the required application on a compatible smartphone
- Willing to wear devices continuously
- Able to provide informed consent
Who cannot join
- Current pregnancy
- Presence of implantable cardiac devices (e.g., permanent pacemakers, implantable cardioverter-defibrillators [ICDs])
- Uncontrolled cardiac arrhythmias (e.g., active atrial fibrillation, frequent premature ventricular contractions [PVCs])
- Movement disorders or active tremors that interfere with blood pressure measurement or signal acquisition (e.g., severe Parkinson's disease, essential tremor)
- Acute medical conditions (e.g., acute coronary syndromes, stroke/TIA within 3 months, acute decompensated heart failure, severe active infections, or hypertensive emergencies)
- Resting blood pressure >=180/110 mmHg
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Faculty of Medical and Life Sciences, Sunway University
Subang Jaya, Selangor, 47500
About this study
Background:
Ambulatory Blood Pressure Monitoring (ABPM) is the gold standard for diagnosing high blood pressure (hypertension) because it tracks blood pressure continuously across day and night. However, standard ABPM requires a cuff that inflates every 15 to 30 minutes during the day and every 30 to 60 minutes at night. These frequent inflations often cause discomfort, interrupt sleep, and cause patients to abandon testing.
Read more
Purpose:
This study aims to evaluate whether a new cuff-based Huawei smartwatch can provide a less-disturbing ABPM experience. Researchers will test whether a reduced-frequency measurement schedule (e.g., 7 readings: 4 awake, 3 asleep) can provide the same diagnostic accuracy as a conventional, full 24-hour ABPM protocol (typically 48 readings) while improving patient comfort.
Study Design \& Procedures:
Study Population:
Approximately 500 adult participants will be recruited over a 24-month study period, with a targeted subgroup of 50 participants selected for clinical validation. The subgroup will represent normotensive, pre-hypertensive, and hypertensive individuals across diverse age groups and ethnicities.
Monitoring \& Comparison: Participants in the validation group will undergo standard 24-hour ABPM at an accredited clinical facility alongside monitoring with the Huawei smartwatch. Data from the smartwatch will be used to compare a reduced-frequency reading schedule against full 24-hour ABPM recordings.
User Feedback: Participants will complete questionnaires assessing comfort, sleep quality, ease of use, and overall preference between the smartwatch and standard ABPM cuffs.
Goal:
The main goal is to determine if a reduced-frequency wearable monitoring protocol can maintain clinical diagnostic accuracy for blood pressure and sleep-dipping patterns while significantly reducing patient burden and sleep disruption.
- Conditions
- Hypertension
- Keywords
- Hypertension, High Blood Pressure, Ambulatory Blood Pressure Monitoring (ABPM), Less-Disturbing ABPM, Reduced-Frequency Monitoring, Wearable Blood Pressure Devices, Smartwatch Blood Pressure, Nocturnal Blood Pressure Dipping, Sleep Disruption and Patient Comfort, Cardiovascular Risk Assessment
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normotensive Cohort | Adult participants with normal blood pressure (defined as blood pressure < 135/85 mmHg; n = 10) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring. | |
| Undiagnosed Elevated Blood Pressure Cohort | Adult participants with undiagnosed elevated blood pressure (defined as blood pressure > 135/85 mmHg; n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring. | |
| Documented Hypertensive Cohort | Adult participants with documented or self-reported hypertension (n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring. | |
| Screening Population | General adult participants recruited across Malaysia who enroll via the Huawei Research Platform app to provide continuous wearable ambulatory blood pressure and physiological data and complete baseline health assessments over the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in Blood Pressure Measured by Reduced-Frequency Smartwatch Schedule Versus Standard 24-Hour Ambulatory Blood Pressure Monitor (ABPM)
Measure Description: Mean blood pressure difference (bias) for 24-hour, daytime, and night-time periods calculated by subtracting reference 24-hour ABPM values (SpaceLabs/Mobil-O-Graph cuff monitor) from reduced-frequency Huawei smartwatch ABPM values (7-measurement schedule).
Unit of Measure: mmHg
Measured: Month 13 through Month 18 (during clinical ABPM validation testing).
Mean Absolute Error (MAE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM
Measure Description: The average absolute difference between blood pressure readings obtained from the reduced-frequency Huawei smartwatch schedule and the standard 24-hour cuff-based ABPM monitor.
Unit of Measure: mmHg
Measured: Month 13 through Month 18.
Root Mean Square Error (RMSE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM
Measure Description: The root mean square error evaluating agreement between blood pressure values recorded by the reduced-frequency Huawei smartwatch schedule and the standard 24-hour cuff-based ABPM monitor.
Unit of Measure: mmHg
Measured: Month 13 through Month 18
Intraclass Correlation Coefficient (ICC) of Blood Pressure Measurements Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM
Measure Description: Agreement reliability calculated using absolute-agreement two-way random-effects ICC comparing reduced-frequency Huawei smartwatch blood pressure estimates against full 24-hour ABPM readings.
Unit of Measure: Intraclass Correlation Coefficient (score ranging from -1.0 to +1.0)
Measured: Month 13 through Month 18
Secondary outcomes (3)
Limits of Agreement (Bland-Altman) for Blood Pressure Readings Between Huawei Smartwatch and Conventional Cuff ABPM
Measure Description: Upper and lower 95% limits of agreement (mean difference +/- 1.96 x standard deviation) calculated via Bland-Altman analysis comparing simultaneous Huawei smartwatch and conventional cuff-based ABPM measurements.
Unit of Measure: mmHg
Measured: Month 13 through Month 18
Participant Comfort Score Evaluated via Post-Monitoring User Experience Survey
Measure Description: Mean total score for participant-reported physical comfort derived from a standardized 5-point Likert scale questionnaire administered immediately after 24-hour monitoring.
Unit of Measure: Score on a scale of 1 to 5 (where 1 = Extreme Discomfort and 5 = Complete Comfort)
Measured: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
Number of Participants Indicating Preference for Smartwatch Monitoring Over Conventional Cuff ABPM
Measure Description: Count of participants who express a preference for smartwatch-based monitoring over traditional arm-cuff ABPM on the post-monitoring user experience survey.
Unit of Measure: Participant count
Measured: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sunway University
- Sponsor type
- University, hospital or other
- Collaborators
- Huawei Device Co., Ltd
- Responsible party
- Principal investigator, YookChin Chia, Sunway University
- Investigators
- Yook Chin Chia, Principal investigator, Sunway UniversityYee How Say, Principal investigator, Sunway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790978
- Sponsor's protocol ID
- Huawei-SU-ABPM-01
- Acronym
- Huawei-SunU2
- Status last verified
- Oct 2026
- First submitted
- 19 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD)-including demographic data, continuous wearable sensor measurements, physiological parameters, and matched conventional ABPM recordings-will be made available to qualified scientific researchers. Data will be shared upon reasonable request to support secondary research, verification of algorithm validation performance, and meta-analyses, provided the proposed use aligns with participant informed consent approvals and local data protection regulations.
Publications
Stergiou GS, Menti A, Mariglis D, Kollias A. The quest for accurate wearable blood pressure monitors. Hypertens Res. 2026 Mar;49(3):1025-1029. doi: 10.1038/s41440-025-02410-w. Epub 2025 Nov 5.
PubMed 41193706McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
PubMed 39210715Kawaja A, Moosa AS, Lee EKP, Phoon IKY, Ang ATW, Chang ZY, Lim ACA, Yap J, Huang W, Ng DX, Sng MY, Loh HY, Ng CJ. Comparison of patients' acceptance of cuff-based vs wearable 24-hour ambulatory blood pressure monitoring devices: A multi-method study. PLoS One. 2025 Nov 17;20(11):e0336961. doi: 10.1371/journal.pone.0336961. eCollection 2025.
PubMed 41248137Islam SMS, Chow CK, Daryabeygikhotbehsara R, Subedi N, Rawstorn J, Tegegne T, Karmakar C, Siddiqui MU, Lambert G, Maddison R. Wearable cuffless blood pressure monitoring devices: a systematic review and meta-analysis. Eur Heart J Digit Health. 2022 May 2;3(2):323-337. doi: 10.1093/ehjdh/ztac021. eCollection 2022 Jun.
PubMed 36713001Chia J, Bhatia KS, Mihailidou AS, Kanagaratnam LB. The Role of Ambulatory Blood Pressure Monitoring in Current Clinical Practice. Heart Lung Circ. 2022 Oct;31(10):1333-1340. doi: 10.1016/j.hlc.2022.06.670. Epub 2022 Aug 4.
PubMed 35934633
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
- ClinicalTrials.gov ID
- NCT07790978
- Acronym / sponsor ID
- Huawei-SunU2 / Huawei-SU-ABPM-01
- Conditions
- Hypertension
- Keywords
- Hypertension, High Blood Pressure, Ambulatory Blood Pressure Monitoring (ABPM), Less-Disturbing ABPM, Reduced-Frequency Monitoring, Wearable Blood Pressure Devices, Smartwatch Blood Pressure, Nocturnal Blood Pressure Dipping
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sunway UniversityUniversity, hospital or other
- Collaborators
- Huawei Device Co., Ltd
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Aug 2026 (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.
Background:
Ambulatory Blood Pressure Monitoring (ABPM) is the gold standard for diagnosing high blood pressure (hypertension) because it tracks blood pressure continuously across day and night. However, standard ABPM requires a cuff that inflates every 15 to 30 minutes during the day and every 30 to 60 minutes at night. These frequent inflations often cause discomfort, interrupt sleep, and cause patients to abandon testing.
Purpose:
This study aims to evaluate whether a new cuff-based Huawei smartwatch can provide a less-disturbing ABPM experience. Researchers will test whether a reduced-frequency measurement schedule (e.g., 7 readings: 4 awake, 3 asleep) can provide the same diagnostic accuracy as a conventional, full 24-hour ABPM protocol (typically 48 readings) while improving patient comfort.
Study Design \& Procedures:
Study Population:
Approximately 500 adult participants will be recruited over a 24-month study period, with a targeted subgroup of 50 participants selected for clinical validation. The subgroup will represent normotensive, pre-hypertensive, and hypertensive individuals across diverse age groups and ethnicities.
Monitoring \& Comparison: Participants in the validation group will undergo standard 24-hour ABPM at an accredited clinical facility alongside monitoring with the Huawei smartwatch. Data from the smartwatch will be used to compare a reduced-frequency reading schedule against full 24-hour ABPM recordings.
User Feedback: Participants will complete questionnaires assessing comfort, sleep quality, ease of use, and overall preference between the smartwatch and standard ABPM cuffs.
Goal:
The main goal is to determine if a reduced-frequency wearable monitoring protocol can maintain clinical diagnostic accuracy for blood pressure and sleep-dipping patterns while significantly reducing patient burden and sleep disruption.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normotensive Cohort | – | –Adult participants with normal blood pressure (defined as blood pressure < 135/85 mmHg; n = 10) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring. |
| Undiagnosed Elevated Blood Pressure Cohort | – | –Adult participants with undiagnosed elevated blood pressure (defined as blood pressure > 135/85 mmHg; n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring. |
| Documented Hypertensive Cohort | – | –Adult participants with documented or self-reported hypertension (n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring. |
| Screening Population | – | –General adult participants recruited across Malaysia who enroll via the Huawei Research Platform app to provide continuous wearable ambulatory blood pressure and physiological data and complete baseline health assessments over the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adult community-dwelling individuals residing in Malaysia recruited via the Huawei Research Platform. From this general screening pool (target N = 500), a targeted clinical validation subgroup (n = 50) will be prospectively selected to undergo dual ABPM and smartwatch evaluation. To ensure clinical applicability and statistical validity in alignment with ISO 81060-2 and AAMI validation standards, the validation subgroup will be stratified into three distinct cohorts: * Normotensive Cohort (n = 10): Participants with blood pressure < 135/85 mmHg. * Undiagnosed Elevated Blood Pressure Cohort (n = 20): Participants with untreated blood pressure > 135/85 mmHg. * Documented Hypertensive Cohort (n = 20): Participants with documented or self-reported history of history of hypertension. Selection across all cohorts will maintain balanced demographic representation across age groups, biological sex, and major Malaysian ethnic populations (Malay, Chinese, Indian)
Key inclusion criteria (7 listed)
- Possesses the specific Huawei wearable required for the study
- Aged ≥18 years
- Malaysian citizen/permanent resident
- Understands English, Malay, or Chinese
- Able to download the required application on a compatible smartphone
Key exclusion criteria (6 listed)
- Current pregnancy
- Presence of implantable cardiac devices (e.g., permanent pacemakers, implantable cardioverter-defibrillators [ICDs])
- Uncontrolled cardiac arrhythmias (e.g., active atrial fibrillation, frequent premature ventricular contractions [PVCs])
- Movement disorders or active tremors that interfere with blood pressure measurement or signal acquisition (e.g., severe Parkinson's disease, essential tremor)
- Acute medical conditions (e.g., acute coronary syndromes, stroke/TIA within 3 months, acute decompensated heart failure, severe active infections, or hypertensive emergencies)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Difference in Blood Pressure Measured by Reduced-Frequency Smartwatch Schedule Versus Standard 24-Hour Ambulatory Blood Pressure Monitor (ABPM)
Time frame: Month 13 through Month 18 (during clinical ABPM validation testing).
Measure Description: Mean blood pressure difference (bias) for 24-hour, daytime, and night-time periods calculated by subtracting reference 24-hour ABPM values (SpaceLabs/Mobil-O-Graph cuff monitor) from reduced-frequency Huawei smartwatch ABPM values (7-measurement schedule). Unit of Measure: mmHg
Mean Absolute Error (MAE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM
Time frame: Month 13 through Month 18.
Measure Description: The average absolute difference between blood pressure readings obtained from the reduced-frequency Huawei smartwatch schedule and the standard 24-hour cuff-based ABPM monitor. Unit of Measure: mmHg
Root Mean Square Error (RMSE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM
Time frame: Month 13 through Month 18
Measure Description: The root mean square error evaluating agreement between blood pressure values recorded by the reduced-frequency Huawei smartwatch schedule and the standard 24-hour cuff-based ABPM monitor. Unit of Measure: mmHg
Intraclass Correlation Coefficient (ICC) of Blood Pressure Measurements Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM
Time frame: Month 13 through Month 18
Measure Description: Agreement reliability calculated using absolute-agreement two-way random-effects ICC comparing reduced-frequency Huawei smartwatch blood pressure estimates against full 24-hour ABPM readings. Unit of Measure: Intraclass Correlation Coefficient (score ranging from -1.0 to +1.0)
3 secondary outcomes
Limits of Agreement (Bland-Altman) for Blood Pressure Readings Between Huawei Smartwatch and Conventional Cuff ABPM
Time frame: Month 13 through Month 18
Participant Comfort Score Evaluated via Post-Monitoring User Experience Survey
Time frame: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
Number of Participants Indicating Preference for Smartwatch Monitoring Over Conventional Cuff ABPM
Time frame: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 41193706Stergiou GS, Menti A, Mariglis D, Kollias A. The quest for accurate wearable blood pressure monitors. Hypertens Res. 2026 Mar;49(3):1025-1029. doi: 10.1038/s41440-025-02410-w. Epub 2025 Nov 5.
- Background: PubMed 39210715McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.
- Background: PubMed 41248137Kawaja A, Moosa AS, Lee EKP, Phoon IKY, Ang ATW, Chang ZY, Lim ACA, Yap J, Huang W, Ng DX, Sng MY, Loh HY, Ng CJ. Comparison of patients' acceptance of cuff-based vs wearable 24-hour ambulatory blood pressure monitoring devices: A multi-method study. PLoS One. 2025 Nov 17;20(11):e0336961. doi: 10.1371/journal.pone.0336961. eCollection 2025.
- Background: PubMed 36713001Islam SMS, Chow CK, Daryabeygikhotbehsara R, Subedi N, Rawstorn J, Tegegne T, Karmakar C, Siddiqui MU, Lambert G, Maddison R. Wearable cuffless blood pressure monitoring devices: a systematic review and meta-analysis. Eur Heart J Digit Health. 2022 May 2;3(2):323-337. doi: 10.1093/ehjdh/ztac021. eCollection 2022 Jun.
- Background: PubMed 35934633Chia J, Bhatia KS, Mihailidou AS, Kanagaratnam LB. The Role of Ambulatory Blood Pressure Monitoring in Current Clinical Practice. Heart Lung Circ. 2022 Oct;31(10):1333-1340. doi: 10.1016/j.hlc.2022.06.670. Epub 2022 Aug 4.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD)-including demographic data, continuous wearable sensor measurements, physiological parameters, and matched conventional ABPM recordings-will be made available to qualified scientific researchers. Data will be shared upon reasonable request to support secondary research, verification of algorithm validation performance, and meta-analyses, provided the proposed use aligns with participant informed consent approvals and local data protection regulations.
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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.
Yook Chin Chia principal investigator
Sunway University
Yee How Say principal investigator
Sunway University
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 Hypertension, run by Sunway University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. 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: opening soon, as of the sponsor's last update on 28 Oct 2026. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yook Chin Chia (+60374918622, ycchia@sunway.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in Blood Pressure Measured by Reduced-Frequency Smartwatch Schedule Versus Standard 24-Hour Ambulatory Blood Pressure Monitor (ABPM) (time frame: Month 13 through Month 18 (during clinical ABPM validation testing).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07790978, which also lists 5 linked publications.
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 28 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.