Vital Signs Collection Via "Comestai" App

Launched by BUZZI CHILDREN'S HOSPITAL · May 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well the "Comestai" app can collect important health measurements, such as blood pressure, heart rate, respiratory rate, and oxygen levels, using mobile phones. The goal is to compare these readings taken from the app with those from standard medical devices to see if they are accurate. The trial will involve about 3,000 participants aged 16 to 65, particularly focusing on individuals who may have conditions like pre-diabetes, diabetes, or high blood pressure.

To participate, individuals must be able to give informed consent and follow the study's procedures. However, some people may not qualify, such as those with certain physical conditions that could affect the measurement or those with severe allergies to materials used in the testing. Each participant will spend about 10-15 minutes recording their health measurements. It’s important to note that a majority of participants will ideally be individuals who are not currently receiving treatment for their medical conditions. If you or someone you know is interested in participating, keep in mind that the study is not yet recruiting, but it’s a chance to help improve health monitoring through technology.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Prior to enrollment in this study, subjects must meet all the following inclusion criteria:
• • 1. Subject must have the ability to understand and provide written informed consent.
• • 2. Male or Female subject ≥16 and ≤65 of age.
• • 3. Subject must be willing and able to comply with study procedures.
• Exclusion Criteria:
• Subjects will be excluded from the study if any of the following conditions are present:
• • 1. 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.
• • 2. Subject has a tattoo in the optical path which would limit the ability to test ROI needed for the study.
• • 3. 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.
• • 4. Subject with a medical condition which in the opinion of the investigator, does not allow performing the study assessments.
• • 5. Subject unfit to participate in the study to the judgment of the investigator.
• 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).