Vital Signs Data Collection Using "Comestai" Application for Non-Invasive Measurement and Validation
Led by Buzzi Children's Hospital · Updated on 2025-11-21
3000
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
Brief Title
Who Can Participate
AI-Screening
Your Study Journey
Trial Site Locations
Research Team
How is the study designed?
Similar Trials
Frequently Asked Questions
Research Publications
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy and reliability of vital sign measurements collected through the "Comestai" mobile application, which uses the front camera of smartphones to non-invasively measure Heart Rate, Respiratory Rate, Oxygen Saturation, and Blood Pressure. The study aims to compare these app measurements with those from standard clinical devices to validate the app's performance. Participants may also consent to share routine blood test results common in evaluations of overweight, obesity, and diabetes.
The study involves collecting vital signs using the "Comestai" app on multiple mobile phones simultaneously while participants sit comfortably with their face uncovered, looking directly at the camera for about 1.5 minutes. At the same time, reference devices measure the same vital signs for comparison. Blood pressure is measured before and after the app data collection. Participants may have several data collection sessions, and consent for blood test results is optional.
Each participant will provide demographic and medical history information, smoking status, physical characteristics, and undergo vital signs recording with both the app and reference devices. Data will be recorded in electronic case report forms. Researchers will analyze the accuracy and correlation between the app and reference devices, using statistical methods to validate measurements. Total participation time is approximately 10 to 15 minutes per session, and no medical decisions will be based on the collected data.
CONDITIONS
Brief Title
Vital Signs Collection Via "Comestai" App
Who Can Participate
Age: 16Years - 65Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
Ability to understand and provide written informed consent
Male or female aged between 16 and 65 years
Willingness and ability to comply with study procedures
You will not qualify if you...
Physical injury, malformation, or compromised circulation in fingers, hands, ears, forehead, or other sensor areas
Presence of tattoos in the optical path affecting sensor placement
Severe allergies to adhesives, latex, or materials in medical sensors
Medical conditions preventing safe study assessments
Investigator judgment deeming participant unfit for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Approximately 10 to 15 minutes per session
Participants will have their vital signs measured using the "Comestai" application and standard reference devices to collect and compare data on heart rate, respiratory rate, oxygen saturation, and blood pressure. Optional blood test results may also be collected with consent.
Vital Sign and Biochemical Data Collection Using Non-contact Photoplethysmography and the Comestai Mobile Health App: Protocol for an Observational Study.
Gianvincenzo Zuccotti, Paolo Osvaldo Agnelli, Lucia Labati...