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RECRUITING

NCT06427564

Vital Signs Collection Via "Comestai" App

Sponsor: Buzzi Children's Hospital

View on ClinicalTrials.gov

Summary

The purpose of the study is to verify and validate the parameters collected from mobile devices via the app named "Comestai" and from reference devices. The assessments considered to define comorbidities are included.. Specifically, collection of vital parameters (Blood Pressure, Heart Rate, Respiratory Rate, Oxygen Saturation) through the "Comestai" Application via mobile phones (using photoplethysmographic method) and reference devices such as Withings-Blood Pressure Monitor Connect® (for Blood Pressure), Polar Verity Sense® (for Heart Rate), Masimo-finger sensor® (for Oxygen Saturation, Respiratory Rate), comparing and confirming them. Consent will be sought for the viewing and collection of blood test results that are normally included in evaluations for subjects with overweight and/or obesity and/or diabetes. Estimated time required for each measurement recording: 10-15 minutes per subject Total number of subjects: 3000

Official title: Vital Signs Data Collection Using "Comestai" Application

Key Details

Gender

All

Age Range

16 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2024-06-01

Completion Date

2026-01-01

Last Updated

2025-11-21

Healthy Volunteers

Yes

Conditions

Vital Signs

Inclusion Criteria: Prior to enrollment in this study, subjects must meet all the following inclusion criteria: 1. Subject must have the ability to understand and provide written informed consent. 2. Male or Female subject ≥16 and ≤65 of age. 3. Subject must be willing and able to comply with study procedures. Exclusion Criteria: Subjects will be excluded from the study if any of the following conditions are present: 1. Subject with compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor Region of Interest (ROI) which would limit the ability to test ROI needed for the study. 2. Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study. 3. Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, respiration monitor electrodes or other medical sensors used for measuring vital signs. 4. Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments. 5. Subject unfit to participate in the study to the judgment of the investigator. In addition to the Inclusion/Exclusion criteria, the 70% of target population should include adult subjects with at least one of the following: * Pre-diabetes or diabetes HbA1C 5.7-13% * \>30% of subjects with HbA1C 5.7-6.4% * \>30% of subjects with HbA1C \>6.4% * Hypertension with systolic measurements above 130 mmHg * \>40% of subjects with systolic BP \>130 mmHg * \>20% of subjects with systolic BP \>160 mmHg * Total cholesterol: \>40% of subjects with \>200 mg/dl and/or LDL above 130 mg/dl * Atrial fibrillation 1% * Smokers \~ 20-30% of all subjects in the study Note: the same subject can have more than one of the above medical conditions. It is preferred that subjects will be treatment- naive for the medical condition they suffer from or are not under treatment at the time of participation (e.g. a subject who suffers from hypertension has not started his treatment to lower his blood pressure).

Locations (1)

ASST-Fatebenefratelli Sacco-Buzzi Children's Hospital

Milan, Italy