[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653284":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":45,"studyPopulation":48,"armGroups":49,"interventions":45,"overallOfficials":56,"centralContacts":60,"locations":68,"responsibleParty":87,"collaborators":90,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":45,"enrollmentInfo":104,"targetDuration":107,"studyType":108,"phases":45,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":123,"whyStopped":45,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Sunway University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":26,"otherOutcomes":35},[9,13,16,19,23],{"measure":10,"description":11,"timeFrame":12},"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.\n\nUnit 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.",{"measure":14,"description":15,"timeFrame":12},"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.\n\nUnit of Measure: Percentage of true positive cases",{"measure":17,"description":18,"timeFrame":12},"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.\n\nUnit of Measure: Percentage of true negative cases",{"measure":20,"description":21,"timeFrame":22},"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.\n\nUnit of Measure: Percentage","Month 11 through Month 18",{"measure":24,"description":25,"timeFrame":22},"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.\n\nUnit of Measure: Percentage",[27,31],{"measure":28,"description":29,"timeFrame":30},"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.\n\nUnit of Measure: Percentage of enrolled participants","Month 1 through Month 12 (up to 12 months per participant)",{"measure":32,"description":33,"timeFrame":34},"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\u002FPoor and 5 = Strongly Agree\u002FExcellent)","At the completion of the wearable monitoring phase (Month 12).",[36,40],{"measure":37,"description":38,"timeFrame":39},"Prevalence of Wearable-Identified High-Risk Flags in the Study Population","Measure Description: The percentage of participants flagged as high-risk for hypertension by the Huawei wearable platform within the total recruited screening cohort.\n\nUnit of Measure: Percentage of total participants","Month 3 through Month 12 (during community-based wearable data collection).",{"measure":41,"description":42,"timeFrame":43},"Association Between Wearable Digital Biomarkers and ABPM-Confirmed Hypertension Risk","Measure Description: Adjusted Odds Ratios derived from logistic regression models assessing the relationship between wearable physiological parameters (heart rate, heart rate variability, sleep duration\u002Fquality, physical activity, and PPG blood pressure estimates) and ABPM-confirmed hypertension status.\n\nUnit of Measure: Adjusted Odds Ratio (OR) with 95% Confidence Intervals","Month 17 through Month 20 (during data cleaning and analytical modelling).",{"allocation":45,"interventionModel":45,"interventionModelDescription":45,"primaryPurpose":45,"observationalModel":46,"timePerspective":47,"maskingInfo":45},null,"ECOLOGIC_OR_COMMUNITY","CROSS_SECTIONAL","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.",[50,53],{"label":51,"type":45,"description":52,"interventionNames":45},"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.",{"label":54,"type":45,"description":55,"interventionNames":45},"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.",[57],{"name":58,"affiliation":5,"role":59},"Yook Chin Chia","PRINCIPAL_INVESTIGATOR",[61,65],{"name":58,"role":62,"phone":63,"phoneExt":45,"email":64},"CONTACT","+60374918622","ycchia@sunway.edu.my",{"name":66,"role":62,"phone":63,"phoneExt":45,"email":67},"Yee How Say","yeehows@sunway.edu.my",[69],{"facility":70,"status":45,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Faculty of Medical and Life Sciences, Sunway University","Subang Jaya","Selangor","47500","Malaysia","MY",{"type":77,"coordinates":78},"Point",[79,80],101.58062,3.04384,{"lat":80,"lon":79},[83,84,85,86],{"name":58,"role":62,"phone":63,"phoneExt":45,"email":64},{"name":66,"role":62,"phone":63,"phoneExt":45,"email":67},{"name":58,"role":59,"phone":45,"phoneExt":45,"email":45},{"name":66,"role":59,"phone":45,"phoneExt":45,"email":45},{"type":59,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"YookChin Chia","Professor Emeritus",[91],{"name":92,"class":93},"Huawei Device Co., Ltd","INDUSTRY","100653284","real-world-validation-of-huawei-wearable-technologies-for-hypertension-risk-screening-in-malaysia-100653284",false,"NCT07785895","Real-World Validation of Huawei Wearable Technologies for Hypertension Risk Screening in Malaysia","Huawei-SunU1","Inclusion Criteria:\n\n* Possesses the specific Huawei wearable required for the study\n* Aged ≥18 years\n* Malaysian citizen\u002Fpermanent resident\n* Understands English, Malay, or Chinese\n* Able to download the required application on a compatible smartphone\n* Willing to wear devices continuously\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* Current pregnancy\n* Implantable cardiac devices (e.g., permanent pacemakers, implantable cardioverter-defibrillators \\[ICDs\\])\n* Uncontrolled arrhythmias (e.g., active atrial fibrillation, frequent premature ventricular contractions \\[PVCs\\])\n* Movement disorders or active tremors that interfere with signal acquisition (e.g., severe Parkinson's disease, essential tremor)\n* Acute medical conditions, including:\n* Acute coronary syndromes (e.g., recent myocardial infarction or unstable angina within the past 3 months)\n* Acute cerebrovascular events (e.g., stroke or transient ischemic attack \\[TIA\\] within the past 3 months)\n* Acute decompensated heart failure or severe respiratory distress\n* Active, severe acute infections or systemic inflammatory illness (e.g., sepsis, acute pneumonia)\n* Hypertensive emergencies or urgency\n* Currently on antihypertensive medications\n* Resting BP ≥180\u002F110 mmHg.",true,"ALL","18 Years",{"count":105,"type":106},500,"ESTIMATED","2 Years","OBSERVATIONAL","Background:\n\nHypertension (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.\n\nPurpose:\n\nThe 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.\n\nStudy Design \\& Procedures:\n\nParticipants: Approximately 500 adults will be enrolled over a 24-month study period.\n\nScreening: All participants will use the Huawei smartwatch screening tool to monitor their blood pressure estimates.\n\nValidation: 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.\n\nGoal:\n\nResearchers 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.",[111],"Hypertension",[111,113,114,115,116,117,118,119,120,121,122],"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","NOT_YET_RECRUITING","2026-08-21",{"date":126,"type":127},"2026-08-25","ACTUAL",{"date":129,"type":106},"2026-10-01",{"date":131,"type":106},"2028-12-31",{"name":5,"class":6},1]