⚡ Quick Summary
This observational study aims to validate the Comestai mobile health app for measuring vital signs and biochemical data using non-contact photoplethysmography. By enrolling 3,000 participants, the study seeks to enhance the accuracy of vital sign detection and support preventive healthcare measures.
🔍 Key Details
- 📊 Participants: 3,000 individuals enrolled consecutively
- 🧩 Vital signs measured: Heart rate, respiratory rate, oxygen saturation, blood pressure
- ⚙️ Technology: Comestai app utilizing non-contact photoplethysmography
- 🏆 Accuracy assessment: Comparison with standard clinical devices
🔑 Key Takeaways
- 📱 Mobile health solutions like Comestai can facilitate early detection of vital sign changes.
- 💡 The study aims to validate the app’s accuracy against traditional clinical devices.
- 👥 A diverse population of 3,000 participants will be analyzed for robust data collection.
- 📈 Key metrics such as sensitivity, specificity, and predictive values will be calculated.
- 🔍 Data collection began in June 2024, with 1,200 participants recruited as of March 2025.
- 🌍 The study’s outcomes are expected to contribute significantly to mobile health technology advancements.
- 🆔 ClinicalTrials.gov Identifier: NCT06427564.
📚 Background
The early detection of vital sign changes is crucial for recognizing patient deterioration, enabling timely interventions that can prevent adverse outcomes. Traditional methods of monitoring vital signs often rely on direct contact, which can be cumbersome and limit accessibility. The advent of mobile health technologies, such as the Comestai app, offers a promising alternative for non-invasive monitoring, potentially transforming patient care.
🗒️ Study
This observational study is designed to assess the accuracy of the Comestai app in measuring vital signs through a non-contact method. Participants will have their faces recorded using the front camera of a mobile device for approximately 1.5 minutes while vital signs are simultaneously collected using standard clinical devices. The study will also gather biochemical data, including hemoglobin and cholesterol levels, to enhance the app’s algorithm.
📈 Results
As of March 25, 2025, the study has successfully recruited 1,200 participants. The analysis will focus on validating the app’s measurements against reference devices and standard tests, employing various statistical methods to ensure accuracy. The final outcomes are anticipated by the end of 2025, promising to provide valuable insights into the app’s effectiveness.
🌍 Impact and Implications
The findings from this study could significantly enhance the accuracy of vital sign detection through non-contact methods. By validating the Comestai app as a reliable screening tool, this research may pave the way for broader applications of mobile health technologies in preventive care. The continuous improvement of artificial intelligence algorithms based on large population data will further reduce errors and enhance patient outcomes.
🔮 Conclusion
This study represents a significant step forward in the integration of mobile health solutions into routine patient monitoring. By leveraging non-contact photoplethysmography, the Comestai app has the potential to revolutionize how vital signs and biochemical indicators are measured, ultimately supporting preventive healthcare initiatives. Continued research in this area is essential for validating and improving these innovative technologies.
💬 Your comments
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Vital Sign and Biochemical Data Collection Using Non-contact Photoplethysmography and the Comestai Mobile Health App: Protocol for an Observational Study.
Abstract
BACKGROUND: Early detection of vital sign changes is key to recognizing patient deterioration promptly, enabling timely interventions and potentially preventing adverse outcomes.
OBJECTIVE: In this study, vital parameters (heart rate, respiratory rate, oxygen saturation, and blood pressure) will be measured using the Comestai app to confirm the accuracy of photoplethysmography methods compared to standard clinical practice devices, analyzing a large and diverse population. In addition, the app will facilitate big data collection to enhance the algorithm’s performance in measuring hemoglobin, glycated hemoglobin, and total cholesterol.
METHODS: A total of 3000 participants will be consecutively enrolled to achieve the objectives of this study. In all patients, personal data, medical condition, and treatment overview will be recorded. The “by face” method for remote photoplethysmography vital sign data collection involves recording participants’ faces using the front camera of a mobile device (iOS or Android) for approximately 1.5 minutes. Simultaneously, vital signs will be continuously collected for about 1.5 minutes using the reference devices alongside data collected via the Comestai app; biochemical results will also be recorded. The accuracy of the app measurements compared to the reference devices and standard tests will be assessed for all parameters. CIs will be calculated using the bootstrap method. The proposed approach’s effectiveness will be evaluated using various quality criteria, including the mean error, SD, mean absolute error, root mean square error, and mean absolute percentage error. The correlation between measurements obtained using the app and reference devices and standard tests will be evaluated using the Pearson correlation coefficient. Agreement between pairs of measurements (app vs reference devices and standard tests) will be represented using Bland-Altman plots. Sensitivity, specificity, positive predictive value, negative predictive value, accuracy, and likelihood ratios will be calculated to determine the ability of the new app to accurately measure vital signs.
RESULTS: Data collection began in June 2024. As of March 25, 2025, we have recruited 1200 participants. The outcomes of the study are expected at the end of 2025. The analysis plan involves verifying and validating the parameters collected from mobile devices via the app, reference devices, and prescheduled blood tests, along with patient demographic data.
CONCLUSIONS: Our study will enhance and support the accuracy of data on vital sign detection through PPG, also introducing measurements of biochemical risk indicators. The evaluation of a large population will allow for continuous improvement in the performance and accuracy of artificial intelligence algorithms, reducing errors. Expanding research on mobile health solutions like Comestai can support preventive care by validating their effectiveness as screening tools and guiding future health care technology developments.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06427564; https://clinicaltrials.gov/study/NCT06427564.
Author: [‘Zuccotti G’, ‘Agnelli PO’, ‘Labati L’, ‘Cordaro E’, ‘Braghieri D’, ‘Balconi S’, ‘Xodo M’, ‘Losurdo F’, ‘Berra CCF’, ‘Pedretti RFE’, ‘Fiorina P’, ‘De Pasquale SM’, ‘Calcaterra V’]
Journal: JMIR Res Protoc
Citation: Zuccotti G, et al. Vital Sign and Biochemical Data Collection Using Non-contact Photoplethysmography and the Comestai Mobile Health App: Protocol for an Observational Study. Vital Sign and Biochemical Data Collection Using Non-contact Photoplethysmography and the Comestai Mobile Health App: Protocol for an Observational Study. 2025; 14:e65229. doi: 10.2196/65229