Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Mean Difference in Blood Pressure Measured by Reduced-Frequency Smartwatch Schedule Versus Standard 24-Hour Ambulatory Blood Pressure Monitor (ABPM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean Difference in Blood Pressure Measured by Reduced-Frequency Smartwatch Schedule Versus Standard 24-Hour Ambulatory Blood Pressure Monitor (ABPM)
时间窗: 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
时间窗: 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
Root Mean Square Error (RMSE) of Blood Pressure Readings Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM
时间窗: 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
Intraclass Correlation Coefficient (ICC) of Blood Pressure Measurements Between Reduced-Frequency Smartwatch Schedule and Standard 24-Hour ABPM
时间窗: 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)
次要结局
- Limits of Agreement (Bland-Altman) for Blood Pressure Readings Between Huawei Smartwatch and Conventional Cuff ABPM(Month 13 through Month 18)
- Participant Comfort Score Evaluated via Post-Monitoring User Experience Survey(Immediately following completion of 24-hour monitoring (Month 13 through Month 18))
- Number of Participants Indicating Preference for Smartwatch Monitoring Over Conventional Cuff ABPM(Immediately following completion of 24-hour monitoring (Month 13 through Month 18))
研究者
YookChin Chia
Professor Emeritus
Sunway University