An observational study in Hypertension, Vascular Disease and Cardiovascular (CV) Risk, sponsored by Sunway University. Enrolling by invitation at 1 site in Malaysia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Sunway University · Observational
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.
6,845 studies on the registry are indexed under Hypertension; 976 are open to participants now.
This study's planned enrollment of 500 is above the median of 212 across 1,393 observational studies indexed under Hypertension.
Browse Hypertension studies →Sunway University is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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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:
Selection across all cohorts will maintain balanced demographic representation across age groups, biological sex, and major Malaysian ethnic populations (Malay, Chinese, Indian)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Adult participants with documented or self-reported hypertension (n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring.
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.
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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Month 13 through Month 18
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
Time frame: 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)
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
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
Time frame: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
Cohen's Kappa Coefficient for Nocturnal Dipping Pattern Classification Concordance
Measure Description: Inter-rater agreement (Cohen's Kappa) for categorizing participants into nocturnal dipping status categories (dipper vs. non-dipper) comparing reduced-frequency smartwatch schedules against standard full-day ABPM. Unit of Measure: Kappa Statistic (score ranging from -1.0 to +1.0)
Time frame: Month 16 through Month 20.
Minimum Number of Measurements Required to Maintain Diagnostic Accurac
Measure Description: The minimum threshold count of active blood pressure inflations required per 24-hour period to maintain an ICC \>= 0.80 relative to standard 24-hour ABPM. Unit of Measure: Number of blood pressure inflations
Time frame: Month 16 through Month 20.
Plan to share: Yes — De-identified individual participant data (IPD) collected during this study will be shared with qualified external researchers. Specific shared data elements include: Demographics \& Baseline Characteristics: De-identified participant age, sex, body mass index, and baseline clinical blood pressure measurements. Wearable Sensor Data: Continuous physiological streams captured via the Huawei Research Platform, including raw photoplethysmography (PPG) signals, heart rate, heart rate variability, physical activity metrics, and sleep tracking parameters. Reference ABPM Data: Matched 24-hour, daytime, and night-time blood pressure and heart rate values, along with derived nocturnal dipping indices, obtained from clinical cuff-based ABPM and reduced-frequency Huawei smartwatch schedules. User Experience Data: De-identified survey scores on device comfort, ease of use, sleep disturbance, and monitoring preference.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Access Start Date: 6 months after the publication of the primary study results in a peer-reviewed journal. Access End Date: 5 years after initial publication.
Access criteria: Method of Access: Data will be made available via a secure, managed data repository (or directly from the Principal Investigator upon formal request). Qualified Requesters: Scientific researchers affiliated with recognized academic, clinical, or research institutions. Request Requirements: Requesters must submit a methodologically sound research proposal and a clear scientific rationale for secondary analysis. Data Use Agreement (DUA): Execution of a formal Data Use Agreement (DUA) is required to ensure data protection, mandate non-re-identification, and enforce secure handling. Compliance: All shared files will be fully de-identified in compliance with the Personal Data Protection Act (PDPA) Malaysia and institutional Ethics Committee guidelines.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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