Real-World Validation of A Minimally Disruptive Ambulatory Blood Pressure Monitoring (ABPM) Huawei Smartwatch in Malaysia (Huawei-SunU02)

October 28, 2026 updated by: YookChin Chia, Sunway University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Subang Jaya, Selangor, Malaysia, 47500
        • Faculty of Medical and Life Sciences, Sunway University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population comprises adult community-dwelling individuals residing in Malaysia recruited via the Huawei Research Platform. From this general screening pool (target N = 500), a targeted clinical validation subgroup (n = 50) will be prospectively selected to undergo dual ABPM and smartwatch evaluation.

To ensure clinical applicability and statistical validity in alignment with ISO 81060-2 and AAMI validation standards, the validation subgroup will be stratified into three distinct cohorts:

  • Normotensive Cohort (n = 10): Participants with blood pressure < 135/85 mmHg.
  • Undiagnosed Elevated Blood Pressure Cohort (n = 20): Participants with untreated blood pressure > 135/85 mmHg.
  • Documented Hypertensive Cohort (n = 20): Participants with documented or self-reported history of history of hypertension.

Selection across all cohorts will maintain balanced demographic representation across age groups, biological sex, and major Malaysian ethnic populations (Malay, Chinese, Indian)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: ECOLOGIC_OR_COMMUNITY
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Normotensive Cohort

Adult participants with normal blood pressure (defined as blood pressure < 135/85 mmHg; n = 10) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring.
Undiagnosed Elevated Blood Pressure Cohort

Adult participants with undiagnosed elevated blood pressure (defined as blood pressure > 135/85 mmHg; n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring.
Documented Hypertensive Cohort

Adult participants with documented or self-reported hypertension (n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring.
Screening Population

General adult participants recruited across Malaysia who enroll via the Huawei Research Platform app to provide continuous wearable ambulatory blood pressure and physiological data and complete baseline health assessments over the study period.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Month 13 through Month 18 (during clinical ABPM validation testing).
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
Month 13 through Month 18.
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
Month 13 through Month 18
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)
Month 13 through Month 18

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Month 13 through Month 18
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)
Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
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
Immediately following completion of 24-hour monitoring (Month 13 through Month 18)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Month 16 through Month 20.
Minimum Number of Measurements Required to Maintain Diagnostic Accurac
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
Month 16 through Month 20.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sunway University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Huawei Device Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yook Chin Chia, Sunway University
  • Principal Investigator: Yee How Say, BSc PhD, Sunway University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Huawei-SunU-MinDisABPMStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) collected during this study will be shared with qualified external researchers. Specific shared data elements include:

  • Demographics & Baseline Characteristics: De-identified participant age, sex, body mass index, and baseline clinical blood pressure measurements.
  • Wearable Sensor Data: Continuous physiological streams captured via the Huawei Research Platform, including raw photoplethysmography (PPG) signals, heart rate, heart rate variability, physical activity metrics, and sleep tracking parameters.
  • Reference ABPM Data: Matched 24-hour, daytime, and night-time blood pressure and heart rate values, along with derived nocturnal dipping indices, obtained from clinical cuff-based ABPM and reduced-frequency Huawei smartwatch schedules.
  • User Experience Data: De-identified survey scores on device comfort, ease of use, sleep disturbance, and monitoring preference.

IPD Sharing Time Frame

Access Start Date: 6 months after the publication of the primary study results in a peer-reviewed journal.

Access End Date: 5 years after initial publication.

IPD Sharing Access Criteria

Method of Access: Data will be made available via a secure, managed data repository (or directly from the Principal Investigator upon formal request).

Qualified Requesters: Scientific researchers affiliated with recognized academic, clinical, or research institutions.

Request Requirements: Requesters must submit a methodologically sound research proposal and a clear scientific rationale for secondary analysis.

Data Use Agreement (DUA): Execution of a formal Data Use Agreement (DUA) is required to ensure data protection, mandate non-re-identification, and enforce secure handling.

Compliance: All shared files will be fully de-identified in compliance with the Personal Data Protection Act (PDPA) Malaysia and institutional Ethics Committee guidelines.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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