Vital SignsNCT06427564
Vital Signs Collection Via "Comestai" App
An observational study of Vital Signs, run by Buzzi Children's Hospital at 1 site in Italy.
Trial 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.. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Signs
- How many people
- 3,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2024to 1 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST-Fatebenefratelli Sacco-Buzzi Children's Hospital
Milan
Valeria Calcaterra
About this study
Official title: Vital Signs Data Collection Using "Comestai" Application
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
Read the detailed description
Early detection of variations in vital parameters allows for the identification of changes in patients' health status and the provision of recommendations for therapeutic adjustments. The application named "Comestai" is a non-invasive and easy-to-use tool that enables the measurement of vital parameters. The app allows users to simultaneously measure vital parameters such as Heart Rate (HR), Respiratory Rate (RR), Oxygen Saturation (SpO2), and Blood Pressure (BP) using the photoplethysmographic method with the front camera of a mobile device.
The use of simultaneous vital parameter measurement systems like apps can enhance self-monitoring of health status and improve patient care. In this study, vital parameters will be measured using the "Comestai" application and compared and validated with measurements from standard clinical practice devices.
Consent will be sought for the viewing and collection of biochemical evaluation results typically required for individuals with overweight and/or obesity and/or diabetes.
"Comestai" Application: This wellness app allows for non-invasive measurement of vital parameters, enabling users to detect SpO2, HR, RR, and BP by looking at the front camera of a mobile device ("By Face"). The measurement method used is Remote Photoplethysmography (rPPG).
This is a prospective, open-label, study to collect vital parameters using the Comestai application by looking at the front camera of a mobile device ("By Face"). The measurement method of the app is Remote Photoplethysmography (rPPG).
The study plans to enroll up to 3000 subjects
Each subject will be assigned a specific identification number (Subject ID). During the evaluation, the following data will be recorded in the Electronic Case Report Form (eCRF):
Medical history of the subject Current or past therapies Demographic data (date of birth, sex) Smoking habits Physical characteristics (height in meters, weight in kilograms, Body Mass Index in kg/m^2, and phototype)
During the 'By Face' measurement of vital parameters with the app, subjects will be asked to sit in a comfortable place, looking at the phone screen (about 25 cm away) with their face fully uncovered (no masks, hats, or any facial accessories). During data collection, the subject should remain still and breathe steadily. The subject will be required to look directly at the camera throughout the data collection process. The 'By Face' data collection mode can be performed on both iOS and Android in parallel, with both devices positioned in front of the subject. HR and blood pressure will also be measured immediately before and after the app measurement.
Data Collection Equipment
For vital signs data collection using the "Comestai" application, the study staff will use the following mobile phones for rPPG "By Face" measurements:
- Face: Apple internet(i)Phone 13 Pro (10 bit) \& Samsung Galaxy S21 Ultra
- Two additional phones will be used as remote:
- One Android phone - Recorder Remote to start the measurement from far.
- One Apple iPhone -Masimo-finger sensor App to collect the data from the Masimo finger sensor.
- Other necessary equipment includes phone stands (two per room of measurement). In addition to the equipment for vital signs data collection using the "Comestai" application, reference devices will measure the subject's vital signs as a point of comparison. rPPG "By Face" vital signs data collection includes videoing the subjects' faces with a mobile device (iOS and Android) front camara for approximately 1.5 minutes.
Vital signs data using the reference devices (i.e., SpO2, RR, BP, PR) will be collected continuously for approximately 1.5 minutes, and simultaneously to the data collected using the "Comestai" application (i.e., "By Face").
Several data collection events (1.5 minutes each) may be performed per subject using the "Comestai" application and reference devices.
BP will be collected using the reference devices prior to data collection using the Comestai application and immediately after completion of data collection using the Comestai application.
During "By Face" data collection, the subjects will be requested to sit in a comfortable place, looking at a screen (distance of ~25cm) with a fully exposed face (not to wear a mask, hat, or any kind of accessory on the face). During data collection, the subject breathing should be stable with minimum movements. The subject will be requested to stare directly towards the camara during the whole data collection process.
"By Face" mode of data collection can be taken for both iOS and Android in parallel when both devices are positioned in front of the subject.
During the "By Face" data collection, SpO2 levels will be monitored continuously using the standard reference device.
Consent will be sought for viewing and collecting the results of pre-scheduled blood tests. Participation is optional, and subjects who do not consent can still proceed with the parameter measurements. In case of acceptance, the following results will be considered:
Complete Blood Count (Hemoglobin, White Blood Cell Count, Neutrophils, Lymphocytes, and Platelets), Hemoglobin Glycosylated (HbA1C), Lipid Profile (Total Cholesterol, Cholesterol-LDL, Cholesterol-HDL, and Triglycerides), Glucose, Alanine transaminase (ALT), Creatinine.
Estimated participation time per subject: approximately 10-15 minutes.
No medical decisions will be based on data obtained through the "Comestai" application, reference devices, or blood sample results.
All data will be recorded in the study's eCRF.
The analysis plan involves verifying and validating the parameters collected from mobile devices via the app and from reference devices, as well as results of pre-scheduled blood tests and patient demographic data. For all parameters, the accuracy of the app measurement compared to the reference device and standard tests will be assessed.
Confidence intervals will be calculated using the bootstrap method. The correlation between measurements using the app and those using reference devices and standard tests will be evaluated using the Pearson correlation coefficient. The agreement between the two measurements (app and reference devices/and standard tests) will be represented using Bland-Altman plots.
- Conditions
- Vital Signs
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 minutes for data collection
Secondary outcomes (2)
Data Collection Storage and Processing-Hemoglobin
Collect, verify and validate Hemoglobin level (g/dl) in data using the Comestai application and results of pre-scheduled blood tests
Hemoglobin level data obtained using the Comestai application and results of pre-scheduled blood tests 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.
Measured: 15 minutes for data collection
Data Collection Storage and Processing-Hemoglobin glycosylated
Collect, verify and validate Hemoglobin glycosylated level (mmol/mol) in data using the Comestai application and results of pre-scheduled blood tests
Hemoglobin glycosylated level data obtained using the Comestai application and and results of pre-scheduled blood tests 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.
Measured: 15 minutes for data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jun 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vital SignsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buzzi Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Calcaterra, Buzzi Children's Hospital
- Investigators
- Gianvincenzo Zuccotti, MD, Prof, Principal investigator, Buzzi Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427564
- Sponsor's protocol ID
- CET 98-2024
- Status last verified
- Nov 2025
- First submitted
- 15 May 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zuccotti G, Agnelli P, Labati L, Cordaro E, Braghieri D, Fiorina P, Bertoli S, Berra CCF, Croci M, Malighetti ME, Losurdo F, Foppiani A, Bucciarelli L, Xodo M, Battezzati A, De Pasquale S, Calcaterra V. Feasibility of a Noncontact Photoplethysmography-Based Mobile App for Noninvasive Hemoglobin Monitoring: Exploratory Observational Study. JMIR Form Res. 2026 Feb 19;10:e78820. doi: 10.2196/78820.
PubMed 41712961Zuccotti 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.
PubMed 40293779
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Signs Data Collection Using "Comestai" Application
- ClinicalTrials.gov ID
- NCT06427564
- Acronym / sponsor ID
- CET 98-2024
- Conditions
- Vital Signs
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Buzzi Children's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Early detection of variations in vital parameters allows for the identification of changes in patients' health status and the provision of recommendations for therapeutic adjustments. The application named "Comestai" is a non-invasive and easy-to-use tool that enables the measurement of vital parameters. The app allows users to simultaneously measure vital parameters such as Heart Rate (HR), Respiratory Rate (RR), Oxygen Saturation (SpO2), and Blood Pressure (BP) using the photoplethysmographic method with the front camera of a mobile device.
The use of simultaneous vital parameter measurement systems like apps can enhance self-monitoring of health status and improve patient care. In this study, vital parameters will be measured using the "Comestai" application and compared and validated with measurements from standard clinical practice devices.
Consent will be sought for the viewing and collection of biochemical evaluation results typically required for individuals with overweight and/or obesity and/or diabetes.
"Comestai" Application: This wellness app allows for non-invasive measurement of vital parameters, enabling users to detect SpO2, HR, RR, and BP by looking at the front camera of a mobile device ("By Face"). The measurement method used is Remote Photoplethysmography (rPPG).
This is a prospective, open-label, study to collect vital parameters using the Comestai application by looking at the front camera of a mobile device ("By Face"). The measurement method of the app is Remote Photoplethysmography (rPPG).
The study plans to enroll up to 3000 subjects
Each subject will be assigned a specific identification number (Subject ID). During the evaluation, the following data will be recorded in the Electronic Case Report Form (eCRF):
Medical history of the subject Current or past therapies Demographic data (date of birth, sex) Smoking habits Physical characteristics (height in meters, weight in kilograms, Body Mass Index in kg/m^2, and phototype)
During the 'By Face' measurement of vital parameters with the app, subjects will be asked to sit in a comfortable place, looking at the phone screen (about 25 cm away) with their face fully uncovered (no masks, hats, or any facial accessories). During data collection, the subject should remain still and breathe steadily. The subject will be required to look directly at the camera throughout the data collection process. The 'By Face' data collection mode can be performed on both iOS and Android in parallel, with both devices positioned in front of the subject. HR and blood pressure will also be measured immediately before and after the app measurement.
Data Collection Equipment
For vital signs data collection using the "Comestai" application, the study staff will use the following mobile phones for rPPG "By Face" measurements:
- Face: Apple internet(i)Phone 13 Pro (10 bit) \& Samsung Galaxy S21 Ultra
- Two additional phones will be used as remote:
- One Android phone - Recorder Remote to start the measurement from far.
- One Apple iPhone -Masimo-finger sensor App to collect the data from the Masimo finger sensor.
- Other necessary equipment includes phone stands (two per room of measurement). In addition to the equipment for vital signs data collection using the "Comestai" application, reference devices will measure the subject's vital signs as a point of comparison. rPPG "By Face" vital signs data collection includes videoing the subjects' faces with a mobile device (iOS and Android) front camara for approximately 1.5 minutes.
Vital signs data using the reference devices (i.e., SpO2, RR, BP, PR) will be collected continuously for approximately 1.5 minutes, and simultaneously to the data collected using the "Comestai" application (i.e., "By Face").
Several data collection events (1.5 minutes each) may be performed per subject using the "Comestai" application and reference devices.
BP will be collected using the reference devices prior to data collection using the Comestai application and immediately after completion of data collection using the Comestai application.
During "By Face" data collection, the subjects will be requested to sit in a comfortable place, looking at a screen (distance of ~25cm) with a fully exposed face (not to wear a mask, hat, or any kind of accessory on the face). During data collection, the subject breathing should be stable with minimum movements. The subject will be requested to stare directly towards the camara during the whole data collection process.
"By Face" mode of data collection can be taken for both iOS and Android in parallel when both devices are positioned in front of the subject.
During the "By Face" data collection, SpO2 levels will be monitored continuously using the standard reference device.
Consent will be sought for viewing and collecting the results of pre-scheduled blood tests. Participation is optional, and subjects who do not consent can still proceed with the parameter measurements. In case of acceptance, the following results will be considered:
Complete Blood Count (Hemoglobin, White Blood Cell Count, Neutrophils, Lymphocytes, and Platelets), Hemoglobin Glycosylated (HbA1C), Lipid Profile (Total Cholesterol, Cholesterol-LDL, Cholesterol-HDL, and Triglycerides), Glucose, Alanine transaminase (ALT), Creatinine.
Estimated participation time per subject: approximately 10-15 minutes.
No medical decisions will be based on data obtained through the "Comestai" application, reference devices, or blood sample results.
All data will be recorded in the study's eCRF.
The analysis plan involves verifying and validating the parameters collected from mobile devices via the app and from reference devices, as well as results of pre-scheduled blood tests and patient demographic data. For all parameters, the accuracy of the app measurement compared to the reference device and standard tests will be assessed.
Confidence intervals will be calculated using the bootstrap method. The correlation between measurements using the app and those using reference devices and standard tests will be evaluated using the Pearson correlation coefficient. The agreement between the two measurements (app and reference devices/and standard tests) will be represented using Bland-Altman plots.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Data Collection Storage and Processing-Pulse rate
Time frame: 15 minutes for data collection
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.
Data Collection Storage and Processing-Oxygen saturation
Time frame: 15 minutes for data collection
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.
Data Collection Storage and Processing-Respiratory rate
Time frame: 15 minutes for data collection
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.
Data Collection Storage and Processing-Blood pressure
Time frame: 15 minutes for data collection
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.
2 secondary outcomes
Data Collection Storage and Processing-Hemoglobin
Time frame: 15 minutes for data collection
Data Collection Storage and Processing-Hemoglobin glycosylated
Time frame: 15 minutes for data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Derived from this study: PubMed 41712961Zuccotti G, Agnelli P, Labati L, Cordaro E, Braghieri D, Fiorina P, Bertoli S, Berra CCF, Croci M, Malighetti ME, Losurdo F, Foppiani A, Bucciarelli L, Xodo M, Battezzati A, De Pasquale S, Calcaterra V. Feasibility of a Noncontact Photoplethysmography-Based Mobile App for Noninvasive Hemoglobin Monitoring: Exploratory Observational Study. JMIR Form Res. 2026 Feb 19;10:e78820. doi: 10.2196/78820.
- Derived from this study: PubMed 40293779Zuccotti 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.
- Individual participant dataSharing planned: No
Related trials for Vital Signs
RecruitingObservational study
Real-world Study of Nerandomilast in Patients With Idiopathic Pulmonary Fibrosis and Progressive Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
Not yet recruiting
Effect of Nurse-Directed Therapeutic Positioning in Children With Pneumonia
Pediatric Pneumonia
Not yet recruiting
Therapeutic Holding Versus Traditional Restraint During Pediatric Venipuncture
Pediatric Venipuncture
Recruiting
VITAL - Virginia Tech Accelerated Holographic LIFU for Anxiety
Anxiety
Not yet recruiting
Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities
Dental Caries, Cavity, Dental
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gianvincenzo Zuccotti, MD, Prof principal investigator
Buzzi Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Signs, run by Buzzi Children's Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gianvincenzo Zuccotti, MD, Prof (+390263631, gianvincenzo.zuccotti@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection Storage and Processing-Pulse rate (time frame: 15 minutes for data collection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06427564, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.