Blood PressureOptiscreenNCT06577688
Smartphone Blood Pressure Measurement to Screen for Hypertension
An observational study of Blood Pressure and Blood Pressure Disorders, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial summary
The goal of this observational study is to assess the feasibility of classifying people whose blood pressures are within hypertensive range using a machine-learning approach based on features derived from smartphone video data recorded at the patient's fingertips. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Blood Pressure Disorders
- What is being tested?
- Blood pressure measurement
- How many people
- 100 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Sep 2024to 30 Dec 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For this study, the aim is to reach balanced classes, with at least 40% of non-hypertensive patients and 40% of hypertensive patients. In order to approach such distributions, both healthy volunteers and patients suspected of hypertension visiting the CHUV Hypertensive Unit for diagnosis confirmation will be recruited.
Who may be able to join
- Informed consent as documented by signature
- Men or women older than 18 years old
- Good understanding of written and oral speaking used at the center where the study will be carried out
Who cannot join
- Patients that cannot sign informed consent
- Patients in emergency situation, are not legally competent, cannot understand the situation or are vulnerable
- Unable to participate due to pain or stress [12]
- Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
- Patients older than 80 years old [4] [13]
- Known pregnancy
Show all 14Show fewer
- Known unstable cardiac condition (myocardial infarction < 1 week, decompensated heart failure, pulmonary embolism)
- End-stage renal disease (GFR < 15/min/1.73m2 and/or dialysis) [4] [14] [15] [16]
- Diabetes mellitus [15] [8]
- Known (or assessed by recording heart rate and using pulse palpation, as recommended in ESC/ESH guidelines [1]) cardiac arrhythmia (atrial fibrillation, numerous extrasystoles and important bradycardia/bradyarrhythmia, bigeminy, trigeminy, isolated VPB) [4] [1] [7] [15] [17]
- SBP or DBP difference between two arms >10 mmHg [8] [18]
- Patient with finger lesions that would alter the correct capture of signals by the mobile phone.
- Known mobile phone contact dermatitis (caused by metal allergens, notably nickel and chromium
- Incapacity of properly using the smartphone (i.e. incapacity of obtaining a recording with sufficient signal quality after the dedicated training)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Maxime Merz contact
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Lausanne
Lausanne, Canton of Vaud, 1011
PATRICK SCHOETTKER, Prof, +41213142007, patrick.schoettker@chuv.ch
Maxime Merz, MD, +41213142007, maxime.merz@chuv.ch
- Recruiting
University Hospital Lausanne CHUV
Lausanne, 1011
Patrick Schoettker, PhD, +41213142007, patrick.schoettker@chuv.ch
About this study
Official title: Assessing the Feasibility of Classifying People Using a Machine-learning Approached Based on Features Derived From Smartphone Video Data Recorded at the Person's Fingertip
The goal of this observational study is to assess the feasibility of classifying people whose blood pressures are within hypertensive range using a machine-learning approach based on features derived from smartphone video data recorded at the patient's fingertips. The main question[s] it aims to answer are:
Is a smartphone a reliable device for high blood pressure screening ? Is a smartphone a reliable device for blood pressure monitoring ? Participants will record their blood pressure with a smartphone at their fingertips and with an approved cuff device, 3 times in the morning and 3 times in the evening for 7 days. There will be two groups, a volunteer presumed healthy, and a volunteer addressed for a Home Blood pressure monitoring with the diagnosis of hypertension suspected.
Researchers will compare the two groups to see if the smartphone can be reliable in terms of diagnosis and monitoring of the blood pressure comparing to a standard cuff device.
Read the detailed description
This is a single-center observational pilot study. Data will be collected prospectively on 100 participants (maximum of 120) with, ideally, 50 presumed healthy volunteers and 50 participants with a suspected diagnosis of hypertension. Presumably healthy volunteers will be recruited via flyers and participants presumed to be hypertensive will be recruited by the hypertension unit of the CHUV, where they are referred for the search for a diagnosis of hypertension.
To comply with the International Hypertension Societies guidelines for LMWH, participants will measure their blood pressure for 7 consecutive days, in the morning (before taking medications and food) and in the evening. (before dinner). At each measurement time point, participants will acquire three separate measurements, one minute apart. Participants will record signals by placing a fingertip of the right hand over a smartphone camera, while simultaneously acquiring a baseline blood pressure measurement using a validated cuff device (WatchBP O3 Ambulatory, Microlife, Widnau, Switzerland) on the left arm. Please note that the smartphone and armband will be provided by the site investigator. The data recorded using the smartphone will be processed and directly compared to the values obtained using the inflatable cuff device.
In accordance with international guidelines for LMWH (except those of the American Heart Association), the threshold for hypertension is set at systolic blood pressure values ≥ 135 mmHg and/or diastolic blood pressure values ≥ 85 mmHg.
The aim of this study is to evaluate the feasibility of classifying people whose blood pressure is in the hypertensive range or not, using a method based on machine learning. To do this, optical data will be recorded at the fingertip from a smartphone camera following the HBPM measurement protocol. The optical signals will then be processed by a machine learning method to obtain the classification. In other words, investigators will attempt to evaluate the reliability of the machine learning method compared to the automatic oscillometric brachial cuff and therefore evaluate the feasibility of using the smartphone as a potential future tool for diagnosis, screening and monitoring hypertension.
The methods of screening, diagnosis and monitoring of hypertensive pathologies are precise but require cumbersome equipment and are sometimes poorly available. Investigators hypothesize that smartphones can be used because of their availability and their capacity to generate quality optical signals, as a discriminating classifier in arterial hypertension thanks to the precision of a machine learning model hypothetically greater than a classification carried out by a random level.
- Conditions
- Blood Pressure, Blood Pressure Disorders
- Being tested
- Blood pressure measurement
- Keywords
- blood pressure, smartphone, Home blood pressure monitoring, Blood pressure disorders screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurementOther
Blood pressure measurement using a standard cuff device and a smartphone
| Study group | Role | What they receive |
|---|---|---|
| Volunteer presumed healthy | People presumed healthy undergoing blood pressure measurement with a standard cuff device and with a Smartphone Receives: Other: Blood pressure measurement | |
| Volunteer suspected of arterial hypertension | People addressed for a suspected diagnosis of arterial hypertension undergoing a home blood pressure monitoring and measurements with a smartphone Receives: Other: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of blood pressure by a smartphone
Reliability of blood pressure measure by smartphone to discriminate values within hypertension range compared to standard cuff device
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Sep 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schoettker, Centre Hospitalier Universitaire Vaudois
- Investigators
- Patrick Schoettker, PhD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577688
- Sponsor's protocol ID
- 2023-00851
- Other IDs
- 2023
- Acronym
- Optiscreen
- Status last verified
- Mar 2026
- First submitted
- 27 Aug 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility of Classifying People Using a Machine-learning Approached Based on Features Derived From Smartphone Video Data Recorded at the Person's Fingertip
- ClinicalTrials.gov ID
- NCT06577688
- Acronym / sponsor ID
- Optiscreen / 2023-00851
- Conditions
- Blood Pressure, Blood Pressure Disorders
- Keywords
- blood pressure, smartphone, Home blood pressure monitoring, Blood pressure disorders screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Aug 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 goal of this observational study is to assess the feasibility of classifying people whose blood pressures are within hypertensive range using a machine-learning approach based on features derived from smartphone video data recorded at the patient's fingertips. The main question[s] it aims to answer are:
Is a smartphone a reliable device for high blood pressure screening ? Is a smartphone a reliable device for blood pressure monitoring ? Participants will record their blood pressure with a smartphone at their fingertips and with an approved cuff device, 3 times in the morning and 3 times in the evening for 7 days. There will be two groups, a volunteer presumed healthy, and a volunteer addressed for a Home Blood pressure monitoring with the diagnosis of hypertension suspected.
Researchers will compare the two groups to see if the smartphone can be reliable in terms of diagnosis and monitoring of the blood pressure comparing to a standard cuff device.
Detailed description
This is a single-center observational pilot study. Data will be collected prospectively on 100 participants (maximum of 120) with, ideally, 50 presumed healthy volunteers and 50 participants with a suspected diagnosis of hypertension. Presumably healthy volunteers will be recruited via flyers and participants presumed to be hypertensive will be recruited by the hypertension unit of the CHUV, where they are referred for the search for a diagnosis of hypertension.
To comply with the International Hypertension Societies guidelines for LMWH, participants will measure their blood pressure for 7 consecutive days, in the morning (before taking medications and food) and in the evening. (before dinner). At each measurement time point, participants will acquire three separate measurements, one minute apart. Participants will record signals by placing a fingertip of the right hand over a smartphone camera, while simultaneously acquiring a baseline blood pressure measurement using a validated cuff device (WatchBP O3 Ambulatory, Microlife, Widnau, Switzerland) on the left arm. Please note that the smartphone and armband will be provided by the site investigator. The data recorded using the smartphone will be processed and directly compared to the values obtained using the inflatable cuff device.
In accordance with international guidelines for LMWH (except those of the American Heart Association), the threshold for hypertension is set at systolic blood pressure values ≥ 135 mmHg and/or diastolic blood pressure values ≥ 85 mmHg.
The aim of this study is to evaluate the feasibility of classifying people whose blood pressure is in the hypertensive range or not, using a method based on machine learning. To do this, optical data will be recorded at the fingertip from a smartphone camera following the HBPM measurement protocol. The optical signals will then be processed by a machine learning method to obtain the classification. In other words, investigators will attempt to evaluate the reliability of the machine learning method compared to the automatic oscillometric brachial cuff and therefore evaluate the feasibility of using the smartphone as a potential future tool for diagnosis, screening and monitoring hypertension.
The methods of screening, diagnosis and monitoring of hypertensive pathologies are precise but require cumbersome equipment and are sometimes poorly available. Investigators hypothesize that smartphones can be used because of their availability and their capacity to generate quality optical signals, as a discriminating classifier in arterial hypertension thanks to the precision of a machine learning model hypothetically greater than a classification carried out by a random level.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volunteer presumed healthy | – | Other: Blood pressure measurementPeople presumed healthy undergoing blood pressure measurement with a standard cuff device and with a Smartphone |
| Volunteer suspected of arterial hypertension | – | Other: Blood pressure measurementPeople addressed for a suspected diagnosis of arterial hypertension undergoing a home blood pressure monitoring and measurements with a smartphone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For this study, the aim is to reach balanced classes, with at least 40% of non-hypertensive patients and 40% of hypertensive patients. In order to approach such distributions, both healthy volunteers and patients suspected of hypertension visiting the CHUV Hypertensive Unit for diagnosis confirmation will be recruited.
Key inclusion criteria (3 listed)
- Informed consent as documented by signature
- Men or women older than 18 years old
- Good understanding of written and oral speaking used at the center where the study will be carried out
Key exclusion criteria (14 listed)
- Patients that cannot sign informed consent
- Patients in emergency situation, are not legally competent, cannot understand the situation or are vulnerable
- Unable to participate due to pain or stress [12]
- Known or suspected non-compliance (e.g. drug or alcohol abuse, language problems, psychological disorders, dementia)
- Patients older than 80 years old [4] [13]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure measurementBlood pressure measurement using a standard cuff device and a smartphone | Other | Volunteer presumed healthy, Volunteer suspected of arterial hypertension |
Primary outcome
Measurement of blood pressure by a smartphone
Time frame: 7 days
Reliability of blood pressure measure by smartphone to discriminate values within hypertension range compared to standard cuff device
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 27 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Maxime Merz contact
Patrick Schoettker, PhD principal investigator
Centre Hospitalier Universitaire Vaudois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure and Blood Pressure Disorders, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
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 3 inclusion and 14 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 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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 Patrick Schoettker, Professor (+41795561043, patrick.schoettker@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of blood pressure by a smartphone (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2026.