HypertensionHuawei-SunU1NCT07785895
Real-World Validation of Huawei Wearable Technologies for Hypertension Risk Screening in Malaysia
An observational study of Hypertension, run by Sunway University at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 500 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Oct 2026to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Faculty of Medical and Life Sciences, Sunway University
Subang Jaya, Selangor, 47500
Yook Chin Chia, +60374918622, ycchia@sunway.edu.my
Yee How Say, +60374918622, yeehows@sunway.edu.my
About this study
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.
Read more
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
- Medical subject headings
- Hypertension, Masked Hypertension, White Coat Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Month 11 through Month 18
Secondary outcomes (2)
Participant Adherence to Huawei Wearable Monitoring Protocols
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
Measured: Month 1 through Month 12 (up to 12 months per participant)
Participant Usability and Acceptance Score Measured via Post-Monitoring Questionnaire
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)
Measured: At the completion of the wearable monitoring phase (Month 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sunway University
- Sponsor type
- University, hospital or other
- Collaborators
- Huawei Device Co., Ltd
- Responsible party
- Principal investigator, YookChin Chia, Sunway University
- Investigators
- Yook Chin Chia, Principal investigator, Sunway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785895
- Sponsor's protocol ID
- Huawei-SU-HTN-01
- Acronym
- Huawei-SunU1
- Status last verified
- Oct 2026
- First submitted
- 18 Aug 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (including physiological measurements, demographic data, and algorithm predictions) may be made available to qualified researchers for academic research purposes upon reasonable request and completion of a Data Transfer/Use Agreement.
Publications
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.
PubMed 41267836Stergiou 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.
PubMed 41193706Odeh 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.
PubMed 39484130McEvoy 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.
PubMed 39210715Islam 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.
PubMed 36713001Chia 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.
PubMed 35934633
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Validation of Huawei Wearable Technologies for Hypertension Risk Screening in Malaysia
- ClinicalTrials.gov ID
- NCT07785895
- Acronym / sponsor ID
- Huawei-SunU1 / Huawei-SU-HTN-01
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sunway UniversityUniversity, hospital or other
- Collaborators
- Huawei Device Co., Ltd
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
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
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
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
2 secondary outcomes
Participant Adherence to Huawei Wearable Monitoring Protocols
Time frame: Month 1 through Month 12 (up to 12 months per participant)
Participant Usability and Acceptance Score Measured via Post-Monitoring Questionnaire
Time frame: At the completion of the wearable monitoring phase (Month 12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 41267836Wang 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.
- Background: PubMed 41193706Stergiou 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.
- Background: PubMed 39484130Odeh 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.
- Background: PubMed 39210715McEvoy 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.
- Background: PubMed 36713001Islam 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.
- Background: PubMed 35934633Chia 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (including physiological measurements, demographic data, and algorithm predictions) may be made available to qualified researchers for academic research purposes upon reasonable request and completion of a Data Transfer/Use Agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yook Chin Chia principal investigator
Sunway University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Sunway University at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yook Chin Chia (+60374918622, ycchia@sunway.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07785895, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.