NCT05236348

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

Single-center Prospective Clinical Trial to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Aktiia SA · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population suffering from hypertension is currently not diagnosed and half of the treated population is not at the defined target of BP. Widespread use of out-of-office Blood Pressure measurement is one of the proposed strategies to fight against hypertension worldwide. Aktiia S.A. has developed an intermittent automated non-invasive cuffless blood pressure monitor, determining the values of the systolic blood pressure, the diastolic blood pressure and the heart rate. This miniature device is comfortably positioned with a bracelet on a user's wrist. The goal of this study is to establish a reasonable assurance of safety and effectiveness with Aktiia OBPM system for monitoring blood pressure in home use. In particular, 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 Blood Pressure changes, during eight visits that will be held over the span of seven days, and generate performance reports.

Conditions

• Hypertension
• Blood Pressure
• Heart Rate

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-01-11
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2022-02-11
• Last updated: 2024-08-19

Locations

1 site across 1 country: Switzerland