An observational study in Hypertension, Vascular Disease Risk 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:
Hypertension (high blood pressure) is a major risk factor for heart disease and stroke, yet many people do not know they have it. In Malaysia, nearly half of all adults with elevated blood pressure are unaware of their condition. Standard clinic blood pressure checks can miss cases of high blood pressure or falsely flag temporary stress-related spikes. While 24-hour Ambulatory Blood Pressure Monitoring (ABPM) is the standard method for an accurate diagnosis, it is not practical for large-scale screening.
Purpose:
The purpose of this study is to evaluate whether a novel Huawei smartwatch, which uses photoplethysmography (PPG) technology to estimate blood pressure, can accurately identify individuals at high risk for hypertension in a real-world setting.
Study Design \& Procedures:
Participants: Approximately 500 adults will be enrolled over a 24-month study period.
Screening: All participants will use the Huawei smartwatch screening tool to monitor their blood pressure estimates.
Validation: A subgroup of approximately 50 participants identified as high-risk by the smartwatch will undergo 24-hour ABPM (the clinical gold standard) to confirm whether they have high blood pressure.
Goal:
Researchers aim to validate the accuracy of the smartwatch screening tool against 24-hour ABPM to determine if wearable technology can support early detection and timely treatment of undiagnosed hypertension in the community.
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.
Counted across the registry records on this site, refreshed daily.
Community-based sample of multi-ethnic Malaysian adults aged 18 years and older. Participants are recruited across Malaysia using digital advertisements via the Huawei Research Platform app, Sunway University community outreach programs, health screening events, corporate wellness initiatives, social media, and primary care clinic referrals. The population includes individuals with compatible smartphones who are willing to wear monitoring devices continuously to assess hypertension risk.
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:
Adults enrolled in the community screening phase who undergo non-invasive blood pressure estimation using the Huawei PPG smartwatch over the 24-month study period.
A targeted subset of participants (n = 50) identified as high-risk for hypertension by the Huawei smartwatch screening tool, who undergo 24-hour Ambulatory Blood Pressure Monitoring (ABPM) to confirm their diagnostic status.
Diagnostic Accuracy (AUC-ROC) of the Huawei PPG Smartwatch Hypertension Risk Algorithm Compared to 24-Hour Ambulatory Blood Pressure Monitoring (ABPM)
Measure Description: Area Under the Receiver Operating Characteristic Curve (AUC-ROC) evaluated by comparing the binary high-risk classification flags generated by the Huawei PPG smartwatch algorithm directly against diagnostic confirmation from clinical 24-hour ABPM. Unit of Measure: Score on a scale from 0.0 to 1.0 (where 0.5 represents chance performance and 1.0 represents perfect discrimination)
Time frame: Month 11 through Month 18.
Diagnostic Sensitivity of the Huawei PPG Smartwatch Hypertension Risk Algorithm
Measure Description: The proportion of participants with true ABPM-confirmed hypertension who are correctly identified as high-risk by the Huawei PPG smartwatch algorithm. Unit of Measure: Percentage of true positive cases
Time frame: Month 11 through Month 18.
Diagnostic Specificity of the Huawei PPG Smartwatch Hypertension Risk Algorithm
Measure Description: The proportion of participants without ABPM-confirmed hypertension who are correctly identified as low-risk by the Huawei PPG smartwatch algorithm. Unit of Measure: Percentage of true negative cases
Time frame: Month 11 through Month 18.
Positive Predictive Value (PPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm
Measure Description: The probability that a participant flagged as high-risk by the Huawei PPG smartwatch algorithm actually has hypertension confirmed by 24-hour ABPM. Unit of Measure: Percentage
Time frame: Month 11 through Month 18
Negative Predictive Value (NPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm
Measure Description: The probability that a participant flagged as low-risk by the Huawei PPG smartwatch algorithm actually does not have hypertension confirmed by 24-hour ABPM. Unit of Measure: Percentage
Time frame: Month 11 through Month 18
Participant Adherence to Huawei Wearable Monitoring Protocols
Measure Description: The proportion of enrolled participants who achieve minimum complete wearable datasets, defined as continuous daily wear of the Huawei smartwatch to track PPG, heart rate, physical activity, and sleep metrics. Unit of Measure: Percentage of enrolled participants
Time frame: Month 1 through Month 12 (up to 12 months per participant)
Participant Usability and Acceptance Score Measured via Post-Monitoring Questionnaire
Measure Description: Total score evaluating participant satisfaction, device comfort, and acceptance of the Huawei wearable for hypertension screening, measured using a standardized post-monitoring user experience questionnaire. Unit of Measure: Mean score on a 1 to 5 Likert scale (where 1 = Strongly Disagree/Poor and 5 = Strongly Agree/Excellent)
Time frame: At the completion of the wearable monitoring phase (Month 12).
Prevalence of Wearable-Identified High-Risk Flags in the Study Population
Measure Description: The percentage of participants flagged as high-risk for hypertension by the Huawei wearable platform within the total recruited screening cohort. Unit of Measure: Percentage of total participants
Time frame: Month 3 through Month 12 (during community-based wearable data collection).
Association Between Wearable Digital Biomarkers and ABPM-Confirmed Hypertension Risk
Measure Description: Adjusted Odds Ratios derived from logistic regression models assessing the relationship between wearable physiological parameters (heart rate, heart rate variability, sleep duration/quality, physical activity, and PPG blood pressure estimates) and ABPM-confirmed hypertension status. Unit of Measure: Adjusted Odds Ratio (OR) with 95% Confidence Intervals
Time frame: Month 17 through Month 20 (during data cleaning and analytical modelling).
Plan to share: Yes — De-identified individual participant data (IPD) collected during the study will be shared with qualified external researchers. The specific data elements to be shared include: Demographic and Baseline Characteristics: De-identified participant age, biological sex, baseline height, weight, body mass index (BMI), and baseline clinical risk factors. Wearable Sensor and Digital Biomarker Data: Continuous physiological, activity, sleep, heart rate, heart rate variability, and photoplethysmography (PPG) data streams acquired directly from the Huawei wearables via the Huawei Research Platform. Clinical Validation and Reference Data: Matched 24-hour Ambulatory Blood Pressure Monitoring (ABPM) confirmation results, clinical hypertension diagnoses, and algorithm risk-scoring outputs generated by the Huawei platform. Participant Experience Data: De-identified scores and responses from post-monitoring usability and device acceptance questionnaires.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Start Date: Data will become available starting 6 months following primary publication of the study results in a peer-reviewed journal. End Date: Data will remain accessible for up to 5 years following initial release.
Access criteria: Where/How to Access: Data will be made available via a secure institutional data repository or upon direct written application to the Principal Investigator. Access Request Process: Qualified researchers must submit a formal scientific proposal outlining the intended use, statistical methodology, and public health relevance. Data Use Agreement (DUA): Requesters must sign a formal Data Use Agreement (DUA) that strictly prohibits any attempt to re-identify participants or share data with unauthorized third parties. Ethical Approval: Requests must include proof of Institutional Review Board (IRB) / Ethics Committee approval or exemption from the requester's home institution. Data Governance \& Compliance: All released data files will be fully anonymized in strict compliance with the Malaysian Personal Data Protection Act (PDPA) and institutional data governance frameworks.
Start is estimated for Nov 2026; primary completion for Oct 2028, 23 months later.
How these figures are worked out, and which studies are left out of them.
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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