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

ConditionHypertension

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorSunway University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Possesses the specific Huawei wearable required for the study

Aged ≥18 years

Malaysian citizen/permanent resident

Understands English, Malay, or Chinese

Disqualifiers

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)

Trial population

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.

Trial design

Design model

Ecologic or community

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

500 Participants

are grouped into 2 trial groups

Group A: Screening Population

Group B: High-Risk Validation Cohort

Trial 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

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).

Other outcomes

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).

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunway University

Lead sponsor

Huawei Device Co., Ltd

Collaborator

Source ClinicalTrials.gov

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