Use smartphone fingertip video to screen and monitor high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center observational pilot will enroll up to 100 adults divided roughly between presumed healthy volunteers and people referred for suspected hypertension. Participants will record fingertip video signals with a site-provided smartphone while simultaneously taking validated cuff blood pressure readings three times in the morning and three times in the evening for seven consecutive days. Machine-learning models will be trained on features derived from the smartphone recordings and compared directly to the cuff measurements to classify blood pressure in the hypertensive range. The study aims to determine whether the smartphone approach can be reliable for both screening and ongoing home monitoring.

Why it matters

Who can join: the full rules

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's running

• University Hospital Lausanne
  Lausanne, Canton of Vaud, Switzerland Recruiting
• University Hospital Lausanne CHUV
  Lausanne, Switzerland Recruiting

Study contacts

• Principal investigator: Patrick Schoettker, PhD — Centre Hospitalier Universitaire Vaudois
• Study coordinator: Patrick Schoettker, Professor
• Email: patrick.schoettker@chuv.ch
• Phone: +41795561043

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.