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NCT Number: NCT07785895

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Masked Hypertension Vascular Diseases White Coat Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    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)

  2. Diagnostic Sensitivity of the Huawei PPG Smartwatch Hypertension Risk Algorithm

    Time frame: 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

  3. Diagnostic Specificity of the Huawei PPG Smartwatch Hypertension Risk Algorithm

    Time frame: 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

  4. Positive Predictive Value (PPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm

    Time frame: 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

  5. Negative Predictive Value (NPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm

    Time frame: 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 outcomes

  1. Participant Adherence to Huawei Wearable Monitoring Protocols

    Time frame: 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

  2. Participant Usability and Acceptance Score Measured via Post-Monitoring Questionnaire

    Time frame: 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)

Other outcomes

  1. Prevalence of Wearable-Identified High-Risk Flags in the Study Population

    Time frame: Month 3 through Month 12 (during community-based wearable data collection).

    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

  2. Association Between Wearable Digital Biomarkers and ABPM-Confirmed Hypertension Risk

    Time frame: Month 17 through Month 20 (during data cleaning and analytical modelling).

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Yee How Say

CONTACT

[email protected]

+60374918622

Yook Chin Chia

CONTACT

[email protected]

+60374918622

Sponsors and collaborators

Lead sponsor

Sunway University

Other

Collaborators

  • Huawei Device Co., Ltd

Registry information

Acronym: Huawei-SunU1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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