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

NCT07785895 | Not Yet Recruiting

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

Brief Summary

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.

Conditions

Hypertension

Keywords

Hypertension; High Blood Pressure; Photoplethysmography (PPG); Ambulatory Blood Pressure Monitoring (ABPM); 24-Hour Ambulatory Blood Pressure; Wearable Health Devices; Smartwatch Blood Pressure Screening; Cardiovascular Disease Risk; Screening and Early Detection; Masked Hypertension; White-Coat Hypertension

Outcome Measures

Primary Outcomes (5)

• Diagnostic Accuracy (AUC-ROC) of the Huawei PPG Smartwatch Hypertension Risk Algorithm Compared to 24-Hour Ambulatory Blood Pressure Monitoring (ABPM)

  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)

  Month 11 through Month 18.

• Diagnostic Sensitivity of the Huawei PPG Smartwatch Hypertension Risk Algorithm

  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

  Month 11 through Month 18.

• Diagnostic Specificity of the Huawei PPG Smartwatch Hypertension Risk Algorithm

  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

  Month 11 through Month 18.

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

  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

  Month 11 through Month 18

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

  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

  Month 11 through Month 18

Secondary Outcomes (2)

• Participant Adherence to Huawei Wearable Monitoring Protocols

  Month 1 through Month 12 (up to 12 months per participant)

• Participant Usability and Acceptance Score Measured via Post-Monitoring Questionnaire

  At the completion of the wearable monitoring phase (Month 12).

Other Outcomes (2)

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

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

• Association Between Wearable Digital Biomarkers and ABPM-Confirmed Hypertension Risk

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

Study Arms (2)

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.

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.

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

Community-based sample of multi-ethnic Malaysian adults aged 18 years and older. Participants are recruited across Malaysia using digital advertisements via the Huawei Research Platform app, Sunway University community outreach programs, health screening events, corporate wellness initiatives, social media, and primary care clinic referrals. The population includes individuals with compatible smartphones who are willing to wear monitoring devices continuously to assess hypertension risk.

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
• 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.

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 (6)

• Wang Y, Zhou SS, Liu YQ, Li DD, Hu SY, Wang X, Yi L, Yu YN, Chen YD. Accessibility and usage patterns of wearable devices among Chinese adults: the Huawei Blood Pressure Health Study. Eur Heart J Digit Health. 2025 Aug 5;6(6):1264-1272. doi: 10.1093/ehjdh/ztaf088. eCollection 2025 Nov.

  PMID: 41267836 BACKGROUND

• 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

• Odeh VA, Chen Y, Wang W, Ding X. Recent Advances in the Wearable Devices for Monitoring and Management of Heart Failure. Rev Cardiovasc Med. 2024 Oct 28;25(10):386. doi: 10.31083/j.rcm2510386. eCollection 2024 Oct.

  PMID: 39484130 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

• 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; Masked Hypertension; White Coat Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yook Chin Chia

  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 18, 2026
• First Posted: August 25, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available starting 6 months after publication of the primary manuscript and for up to 3 years following study completion.
• Access Criteria: Data requests will be reviewed by the Principal Investigators (Sunway University). Requesters must submit a formal research proposal and sign a data use agreement to ensure participant confidentiality under PDPA guidelines.

Locations

MY (1)