Condition: Hypertension · Blood Pressure · Heart Rate · Sponsor: Aktiia SA
This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference measurements. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises. Additionally, this study will compare the heart rate measured by Aktiia.product-us against the reference readings provided by a finger pulse oximeter (as per ISO80601-2-61). The reliability of the auscultation readings will be controlled with simultaneous volume-clamp measurements.
This description comes directly from the study's public registry record.
Josep Sola, PhD · +41797689800 · josep@aktiia.com
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| University of Lausanne Hospitals | Lausanne, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05236348