Smartphone Blood Pressure Measurement to Screen for Hypertension

NCT06577688 | Recruiting

• 1 other identifier: 2023-00851
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Blood Pressure; Blood Pressure Disorders

Keywords

blood pressure; smartphone; Home blood pressure monitoring; Blood pressure disorders screening

Outcome Measures

Primary Outcomes (1)

• 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

  7 days

Study Arms (2)

Volunteer presumed healthy

People presumed healthy undergoing blood pressure measurement with a standard cuff device and with a Smartphone

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

Other: Blood pressure measurement

Interventions

Blood pressure measurement OTHER

Blood pressure measurement using a standard cuff device and a smartphone

Volunteer presumed healthy; Volunteer suspected of arterial hypertension

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (2)

University Hospital Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

University Hospital Lausanne CHUV

Lausanne, 1011, Switzerland

RECRUITING

Study Officials

• Patrick Schoettker, PhD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Schoettker, Professor

CONTACT

+41795561043; patrick.schoettker@chuv.ch

Maxime Merz

CONTACT

maxime.merz@chuv.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

CH (2)