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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Aktiia.product-us
DeviceThe 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.
Treatment groups
225 Participants
are divided into 2 treatment groupsGroup A: Patients 21-60yo with Aktiia.product-usExperimental treatment 1 intervention
Group B: Patients 60-85yo with Aktiia.product-usExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blood pressure mean value of differences
The mean value of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Time frame
1 week2
Blood pressure standard deviation of differences
The standard deviation of the differences between Aktiia.product-us and double auscultation blood pressure measurements.
Time frame
1 weekSecondary outcomes
1
Heart rate root-mean-square error
The root-mean-square difference between the Aktiia.product-us heart rate determinations and the reference method.
Time frame
1 week Source ClinicalTrials.gov