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Your phone as a doctor? new study tests app for vital signs

NCT ID NCT06427564

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Jan 2026

An estimate. End dates often move.

Lead sponsor

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

16 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • ASST-Fatebenefratelli Sacco-Buzzi Children's Hospital

    RECRUITING

    Milan, Italy

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