Trial · NCT07913581
Real-World Validation of A Huawei Smartwatch for Hypertension Risk Screening in Malaysia
NCT07913581, Enrolling by invitation, Sunway University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Real-World Validation of A Huawei Smartwatch for Hypertension Risk Screening in Malaysia. Trials, record NCT07913581. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07913581
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-World Validation of A Huawei Smartwatch for Hypertension Risk Screening in Malaysia
- NCT number
- NCT07913581
- Status
- Enrolling by invitation
- Enrollment
- 500 participants, estimated
- Lead sponsor
- Sunway University
- Conditions
- Hypertension, Vascular Disease Risk, Cardiovascular (CV) Risk, Masked Hypertension, White Coat Hypertension
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diagnostic Accuracy (AUC-ROC) of the Huawei PPG Smartwatch Hypertension Risk Algorithm Compared to 24-Hour Ambulatory Blood Pressure Monitoring (ABPM) | 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) |
| Primary | Diagnostic Sensitivity of the Huawei PPG Smartwatch Hypertension Risk Algorithm | 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 |
| Primary | Diagnostic Specificity of the Huawei PPG Smartwatch Hypertension Risk Algorithm | 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 |
| Primary | Positive Predictive Value (PPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm | 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 |
| Primary | Negative Predictive Value (NPV) of the Huawei PPG Smartwatch Hypertension Risk Algorithm | 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 |
| Secondary | Participant Adherence to Huawei Wearable Monitoring Protocols | Month 1 through Month 12 (up to 12 months per participant) | Measure Description: The proportion of enrolled participants who achieve minimum complete wearable datasets, defined as continuous daily wear of the Huawei smartwatch to track PPG, heart rate, physical activity, and sleep metrics. Unit of Measure: Percentage of enrolled participants |
| Secondary | Participant Usability and Acceptance Score Measured via Post-Monitoring Questionnaire | At the completion of the wearable monitoring phase (Month 12). | Measure Description: Total score evaluating participant satisfaction, device comfort, and acceptance of the Huawei wearable for hypertension screening, measured using a standardized post-monitoring user experience questionnaire. Unit of Measure: Mean score on a 1 to 5 Likert scale (where 1 = Strongly Disagree/Poor and 5 = Strongly Agree/Excellent) |
| Other | Prevalence of Wearable-Identified High-Risk Flags in the Study Population | Month 3 through Month 12 (during community-based wearable data collection). | Measure Description: The percentage of participants flagged as high-risk for hypertension by the Huawei wearable platform within the total recruited screening cohort. Unit of Measure: Percentage of total participants |
| Other | Association Between Wearable Digital Biomarkers and ABPM-Confirmed Hypertension Risk | Month 17 through Month 20 (during data cleaning and analytical modelling). | Measure Description: Adjusted Odds Ratios derived from logistic regression models assessing the relationship between wearable physiological parameters (heart rate, heart rate variability, sleep duration/quality, physical activity, and PPG blood pressure estimates) and ABPM-confirmed hypertension status. Unit of Measure: Adjusted Odds Ratio (OR) with 95% Confidence Intervals |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07913581
GET https://conductscience.org/api/trials/v1/NCT07913581/registered