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NCT Number: NCT06577688

Smartphone Blood Pressure Measurement to Screen for Hypertension

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Lausanne, Lausanne, Canton of Vaud, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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)

Treatment and study plan

Blood pressure measurement

Other

Blood pressure measurement using a standard cuff device and a smartphone

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maxime Merz

CONTACT

[email protected]

Patrick Schoettker, Professor

CONTACT

[email protected]

+41795561043

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study 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

Acronym: Optiscreen

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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