Hypertension
Conditions
Keywords
Hypertension, 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
Brief summary
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.
Interventions
None listed
Sponsors
Sunway University
Huawei Device Co., Ltd
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Root Mean Square Error (RMSE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM | 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 |
| Mean Difference in Blood Pressure Measured by Reduced-Frequency Smartwatch Schedule Versus Standard 24-Hour Ambulatory Blood Pressure Monitor (ABPM) | 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 |
| Mean Absolute Error (MAE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM | 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 |
| Intraclass Correlation Coefficient (ICC) of Blood Pressure Measurements Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Limits of Agreement (Bland-Altman) for Blood Pressure Readings Between Huawei Smartwatch and Conventional Cuff ABPM | 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 |
| Participant Comfort Score Evaluated via Post-Monitoring User Experience Survey | 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) |
| Number of Participants Indicating Preference for Smartwatch Monitoring Over Conventional Cuff ABPM | 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 |
Countries
Malaysia
Contacts
CONTACTYook Chin Chia
CONTACTYee How Say
PRINCIPAL_INVESTIGATORYook Chin Chia
Sunway University
PRINCIPAL_INVESTIGATORYee How Say
Sunway University
Outcome results
None listed