Real-World Validation of A Minimally Disruptive Ambulatory Blood Pressure Monitoring (ABPM) Huawei Smartwatch in Malaysia (Huawei-SunU02)
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.
A tanulmány áttekintése
Állapot
Tanulmány típusa
Beiratkozás (Becsült)
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Selangor
-
Subang Jaya, Selangor, Malaysia, 47500
- Faculty of Medical and Life Sciences, Sunway University
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
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)
Leírás
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Megfigyelési modellek: ECOLOGIC_OR_COMMUNITY
- Időperspektívák: CROSS_SECTIONAL
Kohorszok és beavatkozások
Csoport / Kohorsz |
|---|
|
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. |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Mean Difference in Blood Pressure Measured by Reduced-Frequency Smartwatch Schedule Versus Standard 24-Hour Ambulatory Blood Pressure Monitor (ABPM)
Időkeret: Month 13 through Month 18 (during clinical ABPM validation testing).
|
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
Időkeret: Month 13 through Month 18.
|
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
Időkeret: Month 13 through Month 18
|
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
Időkeret: Month 13 through Month 18
|
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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Limits of Agreement (Bland-Altman) for Blood Pressure Readings Between Huawei Smartwatch and Conventional Cuff ABPM
Időkeret: Month 13 through Month 18
|
Measure Description: Upper and lower 95% limits of agreement (mean difference +/- 1.96 x standard deviation) calculated via Bland-Altman analysis comparing simultaneous Huawei smartwatch and conventional cuff-based ABPM measurements. Unit of Measure: mmHg |
Month 13 through Month 18
|
|
Participant Comfort Score Evaluated via Post-Monitoring User Experience Survey
Időkeret: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
|
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. Unit 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)
|
|
Number of Participants Indicating Preference for Smartwatch Monitoring Over Conventional Cuff ABPM
Időkeret: Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
|
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. Unit of Measure: Participant count |
Immediately following completion of 24-hour monitoring (Month 13 through Month 18)
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Cohen's Kappa Coefficient for Nocturnal Dipping Pattern Classification Concordance
Időkeret: Month 16 through Month 20.
|
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. Unit of Measure: Kappa Statistic (score ranging from -1.0 to +1.0) |
Month 16 through Month 20.
|
|
Minimum Number of Measurements Required to Maintain Diagnostic Accurac
Időkeret: Month 16 through Month 20.
|
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. Unit of Measure: Number of blood pressure inflations |
Month 16 through Month 20.
|
Együttműködők és nyomozók
Szponzor
Együttműködők
Nyomozók
- Kutatásvezető: Yook Chin Chia, Sunway University
- Kutatásvezető: Yee How Say, BSc PhD, Sunway University
Publikációk és hasznos linkek
Általános kiadványok
- 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.
- 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.
- 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.
- 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.
- Stergiou GS, Menti A, Asayama K, Kollias A, Parati G, Schutte AE, Wang J, Aristizabal D, Asmar R, Bilo G, Bothe T, Clark C, Kario K, Li Y, McManus R, Ohkubo T, Palatini P, Picone D, Shimbo D, Tsaganos T, De La Sierra A. Wearable wrist-watch type cuff oscillometric blood pressure monitors: consensus statement by the European Society of Hypertension Working Group on blood pressure monitoring. J Hypertens. 2026 Oct 1;44(10):1721-1731. doi: 10.1097/HJH.0000000000004415. Epub 2026 Aug 26.
- Stergiou GS, Menti A, Asmar R, Bilo G, Ntineri A, Palatini P, Parati G, Shennan A, Wang JG, Sierra A, Kollias A, Schutte AE; STRIDE BP and European Society of Hypertension Working Group on Blood Pressure Monitoring.. Updated practical guide for validation studies of automated cuff blood pressure monitors according to the Universal Standard by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (ISO 81060-2:2018) and Amendments 1:2020 and 2:2024. J Hypertens. 2026 Oct 20. doi: 10.1097/HJH.0000000000004448. Online ahead of print.
- Stergiou GS, Kario K, Aristizabal D, Beheiry H, Cho MC, Colombari DSA, Itoh H, Jafar TH, Jones E, Li Y, Romero CA, Steckelings UM, Williams B, Borghi C, Charchar F, Doku A, Dorobantu M, Flynn J, Khan N, Kollias A, Kreutz R, Mahmud A, Mancia G, Parati G, Poulter N, Reckelhoff J, Renna N, Shehab A, Schlaich M, Schutte A, Teo BW, Tomaszewski M, Touyz R, Wang J, Weber T, Whelton P, Zhang Y. 2026 International Society of Hypertension Global Hypertension Practice Guidelines. J Hypertens. 2026 Oct 20. doi: 10.1097/HJH.0000000000004451. Online ahead of print.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- Huawei-SunU-MinDisABPMStudy
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
De-identified individual participant data (IPD) collected during this study will be shared with qualified external researchers. Specific shared data elements include:
- Demographics & Baseline Characteristics: De-identified participant age, sex, body mass index, and baseline clinical blood pressure measurements.
- Wearable Sensor Data: Continuous physiological streams captured via the Huawei Research Platform, including raw photoplethysmography (PPG) signals, heart rate, heart rate variability, physical activity metrics, and sleep tracking parameters.
- Reference ABPM Data: Matched 24-hour, daytime, and night-time blood pressure and heart rate values, along with derived nocturnal dipping indices, obtained from clinical cuff-based ABPM and reduced-frequency Huawei smartwatch schedules.
- User Experience Data: De-identified survey scores on device comfort, ease of use, sleep disturbance, and monitoring preference.
IPD megosztási időkeret
Access Start Date: 6 months after the publication of the primary study results in a peer-reviewed journal.
Access End Date: 5 years after initial publication.
IPD-megosztási hozzáférési feltételek
Method of Access: Data will be made available via a secure, managed data repository (or directly from the Principal Investigator upon formal request).
Qualified Requesters: Scientific researchers affiliated with recognized academic, clinical, or research institutions.
Request Requirements: Requesters must submit a methodologically sound research proposal and a clear scientific rationale for secondary analysis.
Data Use Agreement (DUA): Execution of a formal Data Use Agreement (DUA) is required to ensure data protection, mandate non-re-identification, and enforce secure handling.
Compliance: All shared files will be fully de-identified in compliance with the Personal Data Protection Act (PDPA) Malaysia and institutional Ethics Committee guidelines.
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ICF
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .