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

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

Inclusion Criteria:

* 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 Criteria:

* 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

Conditions4

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