Hypertension
Conditions
Keywords
Hypertension, High Blood Pressure, Photoplethysmography (PPG), Ambulatory Blood Pressure Monitoring (ABPM), 24-Hour Ambulatory Blood Pressure, Wearable Health Devices, Smartwatch Blood Pressure Screening, Cardiovascular Disease Risk, Screening and Early Detection, Masked Hypertension, White-Coat Hypertension
Brief summary
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.
Interventions
None listed
Sponsors
Sunway University
Huawei Device Co., Ltd
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* Current pregnancy * Implantable cardiac devices (e.g., permanent pacemakers, implantable cardioverter-defibrillators \[ICDs\]) * Uncontrolled arrhythmias (e.g., active atrial fibrillation, frequent premature ventricular contractions \[PVCs\]) * Movement disorders or active tremors that interfere with signal acquisition (e.g., severe Parkinson's disease, essential tremor) * Acute medical conditions, including: * Acute coronary syndromes (e.g., recent myocardial infarction or unstable angina within the past 3 months) * Acute cerebrovascular events (e.g., stroke or transient ischemic attack \[TIA\] within the past 3 months) * Acute decompensated heart failure or severe respiratory distress * Active, severe acute infections or systemic inflammatory illness (e.g., sepsis, acute pneumonia) * Hypertensive emergencies or urgency * Currently on antihypertensive medications * Resting BP ≥180/110 mmHg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy (AUC-ROC) of the Huawei PPG Smartwatch Hypertension Risk Algorithm Compared to 24-Hour Ambulatory Blood Pressure Monitoring (ABPM) | Month 11 through Month 18. | 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) |
| Diagnostic Sensitivity of the Huawei PPG Smartwatch Hypertension Risk Algorithm | Month 11 through Month 18. | 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 |
| Diagnostic Specificity of the Huawei PPG Smartwatch Hypertension Risk Algorithm | Month 11 through Month 18. | 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 |
| Positive Predictive Value (PPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm | Month 11 through Month 18 | 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 |
| Negative Predictive Value (NPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm | Month 11 through Month 18 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Adherence to Huawei Wearable Monitoring Protocols | Month 1 through Month 12 (up to 12 months per participant) | 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 |
| Participant Usability and Acceptance Score Measured via Post-Monitoring Questionnaire | At the completion of the wearable monitoring phase (Month 12). | 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) |
Countries
Malaysia
Contacts
CONTACTYook Chin Chia
CONTACTYee How Say
PRINCIPAL_INVESTIGATORYook Chin Chia
Sunway University
Outcome results
None listed