Real-World Validation of Huawei Wearable Technologies for Hypertension Risk Screening in Malaysia
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
- Diagnostic Accuracy (AUC-ROC) of the Huawei PPG Smartwatch Hypertension Risk Algorithm Compared to 24-Hour Ambulatory Blood Pressure Monitoring (ABPM)
研究概览
简要总结
Background:
Hypertension (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.
Purpose:
The 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.
Study Design & Procedures:
Participants: Approximately 500 adults will be enrolled over a 24-month study period.
Screening: All participants will use the Huawei smartwatch screening tool to monitor their blood pressure estimates.
Validation: 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.
Goal:
Researchers 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.
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
- •Implantable cardiac devices (e.g., permanent pacemakers, implantable cardioverter-defibrillators [ICDs])
- •Uncontrolled arrhythmias (e.g., active atrial fibrillation, frequent premature ventricular contractions [PVCs])
- •Movement disorders or active tremors that interfere with signal acquisition (e.g., severe Parkinson's disease, essential tremor)
- •Acute medical conditions, including:
- •Acute coronary syndromes (e.g., recent myocardial infarction or unstable angina within the past 3 months)
- •Acute cerebrovascular events (e.g., stroke or transient ischemic attack [TIA] within the past 3 months)
- •Acute decompensated heart failure or severe respiratory distress
- •Active, severe acute infections or systemic inflammatory illness (e.g., sepsis, acute pneumonia)
- •Hypertensive emergencies or urgency
- •Currently on antihypertensive medications
- •Resting BP ≥180/110 mmHg.
研究组 & 干预措施
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.
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.
结局指标
主要结局
Diagnostic Accuracy (AUC-ROC) of the Huawei PPG Smartwatch Hypertension Risk Algorithm Compared to 24-Hour Ambulatory Blood Pressure Monitoring (ABPM)
时间窗: Month 11 through Month 18.
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. Unit of Measure: Score on a scale from 0.0 to 1.0 (where 0.5 represents chance performance and 1.0 represents perfect discrimination)
Diagnostic Sensitivity of the Huawei PPG Smartwatch Hypertension Risk Algorithm
时间窗: Month 11 through Month 18.
Measure Description: The proportion of participants with true ABPM-confirmed hypertension who are correctly identified as high-risk by the Huawei PPG smartwatch algorithm. Unit of Measure: Percentage of true positive cases
Diagnostic Specificity of the Huawei PPG Smartwatch Hypertension Risk Algorithm
时间窗: Month 11 through Month 18.
Measure Description: The proportion of participants without ABPM-confirmed hypertension who are correctly identified as low-risk by the Huawei PPG smartwatch algorithm. Unit of Measure: Percentage of true negative cases
Positive Predictive Value (PPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm
时间窗: Month 11 through Month 18
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. Unit of Measure: Percentage
Negative Predictive Value (NPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm
时间窗: Month 11 through Month 18
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. Unit of Measure: Percentage
次要结局
- Participant Adherence to Huawei Wearable Monitoring Protocols(Month 1 through Month 12 (up to 12 months per participant))
- Participant Usability and Acceptance Score Measured via Post-Monitoring Questionnaire(At the completion of the wearable monitoring phase (Month 12).)
研究者
YookChin Chia
Professor Emeritus
Sunway University