Status:
NOT_YET_RECRUITING
Smartphone Blood Pressure Measurement to Screen for Hypertension
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Conditions:
Blood Pressure
Blood Pressure Disorders
Eligibility:
All Genders
18-80 years
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 ...
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 su...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06577688
Start Date
September 1 2024
End Date
September 30 2025
Last Update
August 29 2024
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