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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorAktiia SA

About this trial

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.

Eligibility criteria

Qualifiers

Adult subjects (aged between 21 and 85 years old)

Subjects can read and speak French

Subjects can perform simple physical exercises

Subjects agreeing to attend the totality of 9 visits

Disqualifiers

Clinical staff collaborating with study PI

Subjects with tachycardia (heart rate at rest > 120bpm)

Subjects with atrial fibrillation

Subjects with diabetes

Trial design

Treatments tested in this trial

  • Aktiia.product-us

Treatment groups

225 Participants
are divided into 2 treatment groups

Sponsors and collaborators