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

Sponsor
Sunway University
Study ID
NCT07785895
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

First listed
Aug 25, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Screening Population
    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.
  • Arm: High-Risk Validation Cohort
    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.

Primary Outcome Measure

Diagnostic Accuracy (AUC-ROC) of the Huawei PPG Smartwatch Hypertension Risk Algorithm Compared to 24-Hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: Month 11 through Month 18. ]

Central Contacts

Find similar trials

Nationwide
Hypertension (high blood pressure) trialsCardiology trialsHeart disease trials

Related Studies