Vital Signs Collection Via "Comestai" App
ConditionVital Signs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-65
SponsorBuzzi Children's Hospital
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study.
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.
Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Source ClinicalTrials.gov