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

NCT07790978 | Not Yet Recruiting

• 1 other identifier: Huawei-SU-ABPM-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; High Blood Pressure; Ambulatory Blood Pressure Monitoring (ABPM); Less-Disturbing ABPM; Reduced-Frequency Monitoring; Wearable Blood Pressure Devices; Smartwatch Blood Pressure; Nocturnal Blood Pressure Dipping; Sleep Disruption and Patient Comfort; Cardiovascular Risk Assessment

Outcome Measures

Primary Outcomes (4)

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

  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

  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

  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

  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 Outcomes (3)

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

  Month 13 through Month 18

• Participant Comfort Score Evaluated via Post-Monitoring User Experience Survey

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

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

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

Other Outcomes (2)

• Cohen's Kappa Coefficient for Nocturnal Dipping Pattern Classification Concordance

  Month 16 through Month 20.

• Minimum Number of Measurements Required to Maintain Diagnostic Accuracy

  Month 16 through Month 20.

Study Arms (4)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunway University: lead
• Huawei Device Co., Ltd: collaborator

Study Sites (1)

Faculty of Medical and Life Sciences, Sunway University

Subang Jaya, Selangor, 47500, Malaysia

Location

Related Publications (5)

• Stergiou GS, Menti A, Mariglis D, Kollias A. The quest for accurate wearable blood pressure monitors. Hypertens Res. 2026 Mar;49(3):1025-1029. doi: 10.1038/s41440-025-02410-w. Epub 2025 Nov 5.

  PMID: 41193706 BACKGROUND

• McEvoy JW, McCarthy CP, Bruno RM, Brouwers S, Canavan MD, Ceconi C, Christodorescu RM, Daskalopoulou SS, Ferro CJ, Gerdts E, Hanssen H, Harris J, Lauder L, McManus RJ, Molloy GJ, Rahimi K, Regitz-Zagrosek V, Rossi GP, Sandset EC, Scheenaerts B, Staessen JA, Uchmanowicz I, Volterrani M, Touyz RM; ESC Scientific Document Group. 2024 ESC Guidelines for the management of elevated blood pressure and hypertension. Eur Heart J. 2024 Oct 7;45(38):3912-4018. doi: 10.1093/eurheartj/ehae178. No abstract available.

  PMID: 39210715 BACKGROUND

• Kawaja A, Moosa AS, Lee EKP, Phoon IKY, Ang ATW, Chang ZY, Lim ACA, Yap J, Huang W, Ng DX, Sng MY, Loh HY, Ng CJ. Comparison of patients' acceptance of cuff-based vs wearable 24-hour ambulatory blood pressure monitoring devices: A multi-method study. PLoS One. 2025 Nov 17;20(11):e0336961. doi: 10.1371/journal.pone.0336961. eCollection 2025.

  PMID: 41248137 BACKGROUND

• Islam SMS, Chow CK, Daryabeygikhotbehsara R, Subedi N, Rawstorn J, Tegegne T, Karmakar C, Siddiqui MU, Lambert G, Maddison R. Wearable cuffless blood pressure monitoring devices: a systematic review and meta-analysis. Eur Heart J Digit Health. 2022 May 2;3(2):323-337. doi: 10.1093/ehjdh/ztac021. eCollection 2022 Jun.

  PMID: 36713001 BACKGROUND

• Chia J, Bhatia KS, Mihailidou AS, Kanagaratnam LB. The Role of Ambulatory Blood Pressure Monitoring in Current Clinical Practice. Heart Lung Circ. 2022 Oct;31(10):1333-1340. doi: 10.1016/j.hlc.2022.06.670. Epub 2022 Aug 4.

  PMID: 35934633 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yook Chin Chia

  Sunway University

  PRINCIPAL INVESTIGATOR

• Yee How Say

  Sunway University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yook Chin Chia

CONTACT

+60374918622; ycchia@sunway.edu.my

Yee How Say

CONTACT

+60374918622; yeehows@sunway.edu.my

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available beginning 6 months after publication of the primary study results and will remain accessible for up to 5 years.
• Access Criteria: Eligible Requesters: Qualified academic, clinical, or industry researchers affiliated with a recognized research institution. Method of Request: Requesters must submit a formal research proposal and sign a Data Use Agreement (DUA). Data Governance \& Compliance: All shared data will be fully anonymized in compliance with the Personal Data Protection Act (PDPA) Malaysia and relevant institutional IRB guidelines.

Locations

MY (1)