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Not Yet Recruiting NCT07785895

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

Conditions: Hypertension

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 500
Sponsor: Sunway University

Location: Faculty of Medical and Life Sciences, Sunway University Subang Jaya Selangor

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07785895). StuddyBuddy aggregates publicly available trial information.