RecruitingNot ApplicableNCT05236348

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

Sponsor

Aktiia SA

Enrollment

225 participants

Start Date

Jan 11, 2022

Study Type

INTERVENTIONAL

Conditions

Hypertension Blood Pressure Heart Rate

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.

Eligibility

Min Age: 21 YearsMax Age: 85 Years

Inclusion Criteria5

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
Subjects that have signed the informed consent form

Exclusion Criteria19

Clinical staff collaborating with study PI
Subjects with tachycardia (heart rate at rest \> 120bpm)
Subjects with atrial fibrillation
Subjects with diabetes
Subjects with renal dysfunctions
Subjects with hyper-/hypothyroidism
Subjects with pheochromocytoma
Subjects with Raynaud's disease
Subjects with trembling and shivering
Subjects with interarm systolic difference \> 15 mmHg
Subjects with interarm diastolic difference \> 10 mmHg
Subjects with arm paralysis
Women in known pregnancy (for ARM 1 only)
Subjects with an arteriovenous fistula
Subjects with arm amputations
Subjects with the upper arm circumference \< 22cm or \> 42 cm
Subjects with the wrist circumference \> 21 cm
Subjects with the exfoliative skin diseases
Subjects with lymphoedema

Interventions

DEVICEAktiia.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.