Your phone as a doctor? new study tests app for vital signs
NCT ID NCT06427564
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether a smartphone app called Comestai can accurately measure vital signs like heart rate, breathing rate, oxygen levels, and blood pressure. Researchers will compare the app's readings to those from standard medical devices in 3,000 people aged 16 to 65. The goal is to see if the app is reliable, but no medical decisions will be made based on the results.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 3,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Jan 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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).
- Ages
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16 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ASST-Fatebenefratelli Sacco-Buzzi Children's Hospital
RECRUITINGMilan, Italy
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