Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation

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.

NCT Number	NCT05236348
Lead Sponsor	Aktiia SA
Conditions	Hypertension, Blood Pressure, Heart Rate
Enrollment	225 participants
Start Date	2022-01-11
Primary Completion	2025-03-31 (estimated)
Study Completion	2025-03-31 (estimated)
Updated on ClinicalTrials.gov	2024-08-19