Vital Signs Collection Via "Comestai" App

NCT06427564 | Recruiting

• 1 other identifier: CET 98-2024
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Vital Signs

Outcome Measures

Primary Outcomes (4)

• Data Collection Storage and Processing-Pulse rate

  Collect, verify and validate Pulse rate (beats per minute) in data using the Comestai application and reference devices. Pulse rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.

  15 minutes for data collection

• Data Collection Storage and Processing-Oxygen saturation

  Collect, verify and validate Oxygen saturation (percentage) in data using the Comestai application and reference devices. Oxygen saturation data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.

  15 minutes for data collection

• Data Collection Storage and Processing-Respiratory rate

  Collect, verify and validate Respiratory rate (breaths per minute) in data using the Comestai application and reference devices. Respiratory rate data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.

  15 minutes for data collection

• Data Collection Storage and Processing-Blood pressure

  Collect, verify and validate Blood pressure (mmHg) in data using the Comestai application and reference devices. Blood pressure data obtained using the Comestai application and reference data will be stored on Comestai's secured cloud without any subject identifiable information and will only be recognized using the subject identification number provided during screening. The raw data of subjects' vital signs will be locked, encrypted, and can be read only by Study center team. The measurement method utilized by the app is Remote Photoplethysmography (rPPG). No medical decisions will be made based on the data obtained using the Comestai application, the reference devices, and the pre-scheduled blood sample results.

  15 minutes for data collection

Secondary Outcomes (2)

• Data Collection Storage and Processing-Hemoglobin

  15 minutes for data collection

• Data Collection Storage and Processing-Hemoglobin glycosylated

  15 minutes for data collection

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential adolescent and adult subjects (male and female ≥16 and ≤65 of age), of any race, physiques and skin pigmentation with awide range of health conditions who provided their consent by signing the informed consent form will be screened into the study and provided with a subject specific identification number used throughout the study (i.e. Subject ID).

You may qualify if:

• 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.

You may not qualify if:

• Subjects will be excluded from the study if any of the following conditions are present:
• 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.
• Subject unfit to participate in the study to the judgment of the investigator.
• 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

Sponsors & Collaborators

• Buzzi Children's Hospital: lead

Study Sites (1)

ASST-Fatebenefratelli Sacco-Buzzi Children's Hospital

Milan, Italy

RECRUITING

Related Publications (1)

• Zuccotti G, Agnelli PO, Labati L, Cordaro E, Braghieri D, Balconi S, Xodo M, Losurdo F, Berra CCF, Pedretti RFE, Fiorina P, De Pasquale SM, Calcaterra V. Vital Sign and Biochemical Data Collection Using Non-contact Photoplethysmography and the Comestai Mobile Health App: Protocol for an Observational Study. JMIR Res Protoc. 2025 Apr 28;14:e65229. doi: 10.2196/65229.

  PMID: 40293779 DERIVED

Study Officials

• Gianvincenzo Zuccotti, MD, Prof

  Buzzi Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianvincenzo Zuccotti, MD, Prof

CONTACT

+390263631; gianvincenzo.zuccotti@unimi.it

Valeria Calcaterra, MD

CONTACT

+390263631; valeria.calcaterra@unipv.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 24, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)