[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653776":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":44,"studyPopulation":47,"armGroups":48,"interventions":44,"overallOfficials":61,"centralContacts":67,"locations":74,"responsibleParty":88,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":104,"maxAge":44,"enrollmentInfo":105,"targetDuration":108,"studyType":109,"phases":44,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":123,"whyStopped":44,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Sunway University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":35},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"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\u002FMobil-O-Graph cuff monitor) from reduced-frequency Huawei smartwatch ABPM values (7-measurement schedule).\n\nUnit of Measure: mmHg","Month 13 through Month 18 (during clinical ABPM validation testing).",{"measure":14,"description":15,"timeFrame":16},"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.\n\nUnit of Measure: mmHg","Month 13 through Month 18.",{"measure":18,"description":19,"timeFrame":20},"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.\n\nUnit of Measure: mmHg","Month 13 through Month 18",{"measure":22,"description":23,"timeFrame":20},"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.\n\nUnit of Measure: Intraclass Correlation Coefficient (score ranging from -1.0 to +1.0)",[25,28,32],{"measure":26,"description":27,"timeFrame":20},"Limits of Agreement (Bland-Altman) for Blood Pressure Readings Between Huawei Smartwatch and Conventional Cuff ABPM","Measure Description: Upper and lower 95% limits of agreement (mean difference +\u002F- 1.96 x standard deviation) calculated via Bland-Altman analysis comparing simultaneous Huawei smartwatch and conventional cuff-based ABPM measurements.\n\nUnit of Measure: mmHg",{"measure":29,"description":30,"timeFrame":31},"Participant Comfort Score Evaluated via Post-Monitoring User Experience Survey","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.\n\nUnit 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)",{"measure":33,"description":34,"timeFrame":31},"Number of Participants Indicating Preference for Smartwatch Monitoring Over Conventional Cuff ABPM","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.\n\nUnit of Measure: Participant count",[36,40],{"measure":37,"description":38,"timeFrame":39},"Cohen's Kappa Coefficient for Nocturnal Dipping Pattern Classification Concordance","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.\n\nUnit of Measure: Kappa Statistic (score ranging from -1.0 to +1.0)","Month 16 through Month 20.",{"measure":41,"description":42,"timeFrame":39},"Minimum Number of Measurements Required to Maintain Diagnostic Accuracy","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.\n\nUnit of Measure: Number of blood pressure inflations",{"allocation":44,"interventionModel":44,"interventionModelDescription":44,"primaryPurpose":44,"observationalModel":45,"timePerspective":46,"maskingInfo":44},null,"ECOLOGIC_OR_COMMUNITY","CROSS_SECTIONAL","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.\n\nTo 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:\n\n* Normotensive Cohort (n = 10): Participants with blood pressure \\\u003C 135\u002F85 mmHg.\n* Undiagnosed Elevated Blood Pressure Cohort (n = 20): Participants with untreated blood pressure \\> 135\u002F85 mmHg.\n* Documented Hypertensive Cohort (n = 20): Participants with documented or self-reported history of history of hypertension.\n\nSelection across all cohorts will maintain balanced demographic representation across age groups, biological sex, and major Malaysian ethnic populations (Malay, Chinese, Indian)",[49,52,55,58],{"label":50,"type":44,"description":51,"interventionNames":44},"Normotensive Cohort","Adult participants with normal blood pressure (defined as blood pressure \\\u003C 135\u002F85 mmHg; n = 10) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring.",{"label":53,"type":44,"description":54,"interventionNames":44},"Undiagnosed Elevated Blood Pressure Cohort","Adult participants with undiagnosed elevated blood pressure (defined as blood pressure \\> 135\u002F85 mmHg; n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring.",{"label":56,"type":44,"description":57,"interventionNames":44},"Documented Hypertensive Cohort","Adult participants with documented or self-reported hypertension (n = 20) who undergo simultaneous standard 24-hour ABPM and Huawei smartwatch monitoring.",{"label":59,"type":44,"description":60,"interventionNames":44},"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.",[62,65],{"name":63,"affiliation":5,"role":64},"Yook Chin Chia","PRINCIPAL_INVESTIGATOR",{"name":66,"affiliation":5,"role":64},"Yee How Say",[68,72],{"name":63,"role":69,"phone":70,"phoneExt":44,"email":71},"CONTACT","+60374918622","ycchia@sunway.edu.my",{"name":66,"role":69,"phone":70,"phoneExt":44,"email":73},"yeehows@sunway.edu.my",[75],{"facility":76,"status":44,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":44},"Faculty of Medical and Life Sciences, Sunway University","Subang Jaya","Selangor","47500","Malaysia","MY",{"type":83,"coordinates":84},"Point",[85,86],101.58062,3.04384,{"lat":86,"lon":85},{"type":64,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"YookChin Chia","Professor Emeritus",[92],{"name":93,"class":94},"Huawei Device Co., Ltd","INDUSTRY","100653776","real-world-validation-for-less-disturbing-ambulatory-blood-pressure-monitoring-abpm-in-malaysia-using-huawei-wearables-100653776",false,"NCT07790978","Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables","Huawei-SunU2","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* Presence of implantable cardiac devices (e.g., permanent pacemakers, implantable cardioverter-defibrillators \\[ICDs\\])\n* Uncontrolled cardiac arrhythmias (e.g., active atrial fibrillation, frequent premature ventricular contractions \\[PVCs\\])\n* Movement disorders or active tremors that interfere with blood pressure measurement or signal acquisition (e.g., severe Parkinson's disease, essential tremor)\n* Acute medical conditions (e.g., acute coronary syndromes, stroke\u002FTIA within 3 months, acute decompensated heart failure, severe active infections, or hypertensive emergencies)\n* Resting blood pressure \\>=180\u002F110 mmHg",true,"ALL","18 Years",{"count":106,"type":107},500,"ESTIMATED","2 Years","OBSERVATIONAL","Background:\n\nAmbulatory 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.\n\nPurpose:\n\nThis 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.\n\nStudy Design \\& Procedures:\n\nStudy Population:\n\nApproximately 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.\n\nMonitoring \\& 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.\n\nUser Feedback: Participants will complete questionnaires assessing comfort, sleep quality, ease of use, and overall preference between the smartwatch and standard ABPM cuffs.\n\nGoal:\n\nThe 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.",[112],"Hypertension",[112,114,115,116,117,118,119,120,121,122],"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","NOT_YET_RECRUITING","2026-08-25",{"date":126,"type":127},"2026-08-27","ACTUAL",{"date":129,"type":107},"2026-12-01",{"date":131,"type":107},"2028-12-31",{"name":5,"class":6},1]