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

Recruiting now · Not applicable

Conditions studied: Hypertension, Blood Pressure, Heart Rate

In brief

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.

Key facts

Study ID

NCT05236348

Run by

Aktiia SA

People needed

225

Starts

2022-01-11

Expected to finish

2025-03-31

Last updated by the study team

2024-08-19

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Lausanne Hospitals — Lausanne, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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