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NCT Number: NCT07790978

Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables

Background:

Ambulatory Blood Pressure Monitoring (ABPM) is the gold standard for diagnosing high blood pressure (hypertension) because it tracks blood pressure continuously across day and night. However, standard ABPM requires a cuff that inflates every 15 to 30 minutes during the day and every 30 to 60 minutes at night. These frequent inflations often cause discomfort, interrupt sleep, and cause patients to abandon testing.

Purpose:

This study aims to evaluate whether a new cuff-based Huawei smartwatch can provide a less-disturbing ABPM experience. Researchers will test whether a reduced-frequency measurement schedule (e.g., 7 readings: 4 awake, 3 asleep) can provide the same diagnostic accuracy as a conventional, full 24-hour ABPM protocol (typically 48 readings) while improving patient comfort.

Study Design & Procedures:

Study Population:

Approximately 500 adult participants will be recruited over a 24-month study period, with a targeted subgroup of 50 participants selected for clinical validation. The subgroup will represent normotensive, pre-hypertensive, and hypertensive individuals across diverse age groups and ethnicities.

Monitoring & Comparison: Participants in the validation group will undergo standard 24-hour ABPM at an accredited clinical facility alongside monitoring with the Huawei smartwatch. Data from the smartwatch will be used to compare a reduced-frequency reading schedule against full 24-hour ABPM recordings.

User Feedback: Participants will complete questionnaires assessing comfort, sleep quality, ease of use, and overall preference between the smartwatch and standard ABPM cuffs.

Goal:

The main goal is to determine if a reduced-frequency wearable monitoring protocol can maintain clinical diagnostic accuracy for blood pressure and sleep-dipping patterns while significantly reducing patient burden and sleep disruption.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medical and Life Sciences, Sunway University

Subang Jaya, Selangor, 47500, Malaysia

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
  • Presence of implantable cardiac devices (e.g., permanent pacemakers, implantable cardioverter-defibrillators [ICDs])
  • Uncontrolled cardiac arrhythmias (e.g., active atrial fibrillation, frequent premature ventricular contractions [PVCs])
  • Movement disorders or active tremors that interfere with blood pressure measurement or signal acquisition (e.g., severe Parkinson's disease, essential tremor)
  • Acute medical conditions (e.g., acute coronary syndromes, stroke/TIA within 3 months, acute decompensated heart failure, severe active infections, or hypertensive emergencies)
  • Resting blood pressure >=180/110 mmHg

Treatment and study plan

Primary outcomes

  1. Mean Difference in Blood Pressure Measured by Reduced-Frequency Smartwatch Schedule Versus Standard 24-Hour Ambulatory Blood Pressure Monitor (ABPM)

    Time frame: Month 13 through Month 18 (during clinical ABPM validation testing).

    Measure Description: Mean blood pressure difference (bias) for 24-hour, daytime, and night-time periods calculated by subtracting reference 24-hour ABPM values (SpaceLabs/Mobil-O-Graph cuff monitor) from reduced-frequency Huawei smartwatch ABPM values (7-measurement schedule).

    Unit of Measure: mmHg

  2. Mean Absolute Error (MAE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM

    Time frame: Month 13 through Month 18.

    Measure Description: The average absolute difference between blood pressure readings obtained from the reduced-frequency Huawei smartwatch schedule and the standard 24-hour cuff-based ABPM monitor.

    Unit of Measure: mmHg

  3. Root Mean Square Error (RMSE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM

    Time frame: Month 13 through Month 18

    Measure Description: The root mean square error evaluating agreement between blood pressure values recorded by the reduced-frequency Huawei smartwatch schedule and the standard 24-hour cuff-based ABPM monitor.

    Unit of Measure: mmHg

  4. Intraclass Correlation Coefficient (ICC) of Blood Pressure Measurements Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM

    Time frame: Month 13 through Month 18

    Measure Description: Agreement reliability calculated using absolute-agreement two-way random-effects ICC comparing reduced-frequency Huawei smartwatch blood pressure estimates against full 24-hour ABPM readings.

    Unit of Measure: Intraclass Correlation Coefficient (score ranging from -1.0 to +1.0)

Secondary outcomes

  1. Limits of Agreement (Bland-Altman) for Blood Pressure Readings Between Huawei Smartwatch and Conventional Cuff ABPM

    Time frame: Month 13 through Month 18

    Measure Description: Upper and lower 95% limits of agreement (mean difference +/- 1.96 x standard deviation) calculated via Bland-Altman analysis comparing simultaneous Huawei smartwatch and conventional cuff-based ABPM measurements.

    Unit of Measure: mmHg

  2. Participant Comfort Score Evaluated via Post-Monitoring User Experience Survey

    Time frame: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)

    Measure Description: Mean total score for participant-reported physical comfort derived from a standardized 5-point Likert scale questionnaire administered immediately after 24-hour monitoring.

    Unit of Measure: Score on a scale of 1 to 5 (where 1 = Extreme Discomfort and 5 = Complete Comfort)

  3. Number of Participants Indicating Preference for Smartwatch Monitoring Over Conventional Cuff ABPM

    Time frame: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)

    Measure Description: Count of participants who express a preference for smartwatch-based monitoring over traditional arm-cuff ABPM on the post-monitoring user experience survey.

    Unit of Measure: Participant count

Other outcomes

  1. Cohen's Kappa Coefficient for Nocturnal Dipping Pattern Classification Concordance

    Time frame: Month 16 through Month 20.

    Measure Description: Inter-rater agreement (Cohen's Kappa) for categorizing participants into nocturnal dipping status categories (dipper vs. non-dipper) comparing reduced-frequency smartwatch schedules against standard full-day ABPM.

    Unit of Measure: Kappa Statistic (score ranging from -1.0 to +1.0)

  2. Minimum Number of Measurements Required to Maintain Diagnostic Accuracy

    Time frame: Month 16 through Month 20.

    Measure Description: The minimum threshold count of active blood pressure inflations required per 24-hour period to maintain an ICC >= 0.80 relative to standard 24-hour ABPM.

    Unit of Measure: Number of blood pressure inflations

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-SunU2

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 27, 2026
Registry last updated
Aug 27, 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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