Real-World Validation of Huawei Wearable Technologies for Hypertension Risk Screening in Malaysia

N/ANot Yet RecruitingNCT07785895

Sunway University500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Hypertension

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).

Real-World Validation of Huawei Wearable Technologies for Hypertension Risk Screening in Malaysia

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts