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Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
Sponsor: Aktiia SA
Summary
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.
Official title: Single-center Prospective Clinical Trial to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
Key Details
Gender
All
Age Range
21 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
225
Start Date
2022-01-11
Completion Date
2025-03-31
Last Updated
2024-08-19
Healthy Volunteers
Yes
Conditions
Interventions
Aktiia.product-us
The study will collect data from subjects by means of the device under test and collect data from subjects by means of double-auscultation, pulse oximetry and volume-clamp BP reading while subjects wear the devices at different body positions and induce BP changes, during eight visits that will be held over the span of seven days, and generate performance reports.
Locations (1)
University of Lausanne Hospitals
Lausanne, Switzerland