Vital Signs Data Collection Using Comestai Application

Status: Recruiting
Location: See location...
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Maximum Age: 65
Healthy Volunteers: t
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⁃ Prior to enrollment in this study, subjects must meet all the following inclusion criteria:

• Subject must have the ability to understand and provide written informed consent.

• Male or Female subject ≥16 and ≤65 of age.

• Subject must be willing and able to comply with study procedures.

Locations
Other Locations
Italy
ASST-Fatebenefratelli Sacco-Buzzi Children's Hospital
RECRUITING
Milan
Contact Information
Primary
Gianvincenzo Zuccotti, MD, Prof
gianvincenzo.zuccotti@unimi.it
+390263631
Backup
Valeria Calcaterra, MD
valeria.calcaterra@unipv.it
+390263631
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 3000
Related Therapeutic Areas
Sponsors
Leads: Buzzi Children's Hospital

This content was sourced from clinicaltrials.gov