Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427564
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-15
Brief Title:
Vital Signs Collection Via Comestai App
Sponsor:
Buzzi Childrens Hospital
Organization:
Buzzi Childrens Hospital
Study Overview
Official Title:
Vital Signs Data Collection Using Comestai Application
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor obesity andor diabetes
Estimated time required for each measurement recording 10-15 minutes per subject
Total number of subjects 3000
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 andor obesity andor 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 kgm2 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 internetiPhone 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 subjects 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 15 minutes
Vital signs data using the reference devices ie SpO2 RR BP PR will be collected continuously for approximately 15 minutes and simultaneously to the data collected using the Comestai application ie By Face
Several data collection events 15 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 studys 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 devicesand standard tests will be represented using Bland-Altman plots
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 andor obesity andor 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 kgm2 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 internetiPhone 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 subjects 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 15 minutes
Vital signs data using the reference devices ie SpO2 RR BP PR will be collected continuously for approximately 15 minutes and simultaneously to the data collected using the Comestai application ie By Face
Several data collection events 15 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 studys 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 devicesand standard tests will be represented using Bland-Altman plots
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None