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

Launched by AKTIIA SA · Feb 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the Aktiia Optical Blood Pressure Monitoring Device to see how accurately it measures blood pressure compared to the standard method known as double auscultation. The trial will involve 225 participants who will be monitored over nine visits. To help create different blood pressure readings, participants will do various activities, like changing positions and performing simple exercises. Additionally, the study will check how well the Aktiia device measures heart rate compared to a finger pulse oximeter, which is a tool that measures the amount of oxygen in your blood and heart rate.

To be eligible for this study, participants must be adults aged between 21 and 85, be able to read and speak French, and be willing to attend all nine visits. However, certain conditions would exclude someone from participating, such as having a very fast heartbeat, diabetes, or certain heart or arm issues. If you join the study, you can expect regular visits where your blood pressure and heart rate will be measured while you perform some light exercises. This trial is important because it could help determine if the Aktiia device is a reliable alternative for monitoring blood pressure and heart rate, which could improve how we manage hypertension in the future.

Gender

ALL

Eligibility criteria

• 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