Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring Device at the Wrist Compared to Double Auscultation

What this Trial Is About

Researchers are evaluating the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device, worn on the wrist, by comparing its readings to traditional double auscultation blood pressure measurements taken at the upper arm. This single-center prospective observational study aims to validate the device's accuracy and stability over a four-week period. The study addresses the global challenge of hypertension diagnosis and management, highlighting the limitations of conventional cuff-based methods and offering a more comfortable, cuffless alternative for long-term blood pressure monitoring. The study involves several participant groups, including adults aged 21 to 85 years, diabetics, older adults, individuals with chronic kidney disease, heart failure patients, pregnant women, and postpartum subjects. The Aktiia.device uses optical sensors to capture skin pulsatility via photoplethysmography, estimating systolic and diastolic blood pressure and heart rate without using a cuff. Participants wear the device on their wrist during monitoring, and measurements are taken automatically in various body positions and after aerobic exercise. The study includes multiple visits over four weeks to assess the device's performance across these diverse groups. Participants engage in four visits during the study for blood pressure and heart rate measurements using both the Aktiia device and double auscultation. Researchers measure the absolute mean error and standard deviation of the blood pressure readings compared to reference methods, as well as heart rate error over the four-week duration. The study also monitors participant comfort, device wearability, and measurement stability in different conditions. The total participation time spans up to four weeks, with continuous monitoring and data collection to evaluate the device's potential for integrating blood pressure monitoring into daily life.

Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation