Smartphone Blood Pressure Measurement to Screen for Hypertension
Recruiting · NCT06577688 · Observational (researchers observe without assigning treatment) · Lead sponsor: Centre Hospitalier Universitaire Vaudois
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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)
Where it is running
2 locations listed.
- University Hospital Lausanne CHUV - Lausanne, Switzerland
- University Hospital Lausanne - Lausanne, Canton of Vaud, Switzerland