Actively Recruiting

Age: 16Years - 65Years
All Genders
Healthy Volunteers
ID06427564

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

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

Eligible

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
Not Eligible

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

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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.

1 to 2 visits depending on data collection needs

Trial Site Locations

Total: 1 location

1

ASST-Fatebenefratelli Sacco-Buzzi Children's Hospital

Milan, Italy

Actively Recruiting

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Research Team

G

Gianvincenzo Zuccotti, MD, Prof

V

Valeria Calcaterra, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Frequently Asked Questions

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Published Research Related To This Trial

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...

https://pubmed.ncbi.nlm.nih.gov/40293779