Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

Launched by AKTIIA SA · Jul 18, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the Aktiia optical blood pressure monitor, which is worn on the wrist. The goal is to see how well this wrist monitor works compared to the traditional method of measuring blood pressure using a stethoscope and cuff on the upper arm. The study will take place over four weeks, and researchers want to gather information on its effectiveness and reliability in measuring blood pressure.

To participate in this study, you need to be an adult between the ages of 21 and 85, and you should be able to read and speak French. You will need to attend four visits to the study site and agree to participate after understanding the details. However, certain health conditions may prevent you from joining, such as having very high heart rates, diabetes, or specific arm sizes. If you qualify, you’ll be helping to test a new way of monitoring blood pressure, which could make it easier and more comfortable for people in the future.

Gender

ALL

Eligibility criteria

• • ARM1
• Inclusion Criteria:
• • Adult subjects (aged between 21 and 65 years old)
• • Subjects fluent in written and spoken French
• • Subjects agreeing to attend the totality of 4 visits
• • Subjects that have signed the informed consent form
• Exclusion Criteria:
• • Subjects with tachycardia (heart rate at rest \> 120bpm)
• • Subjects with atrial fibrillation
• • Subjects with diabetes
• • Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2)
• • 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
• • Subjects with an arteriovenous fistula
• • Subjects with arm amputations
• • Subjects with the upper arm circumference \> 64 cm
• • Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size)
• • Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm
• • Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
• • Subjects with lymphoedema (limitation due to participant discomfort)
• • ARM2
• Inclusion Criteria:
• • Adult subjects (aged between 21 and 65 years old)
• • Subjects fluent in written and spoken French
• • Subjects agreeing to attend the totality of 4 visits
• • Subjects that have signed the informed consent form
• Exclusion Criteria:
• • Subjects with tachycardia (heart rate at rest \> 120bpm)
• • Subjects with atrial fibrillation
• • 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
• • Subjects with an arteriovenous fistula
• • Subjects with arm amputations
• • Subjects with the upper arm circumference \> 64 cm
• • Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size)
• • Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm
• • Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
• • Subjects with lymphoedema (limitation due to participant discomfort)
• • ARM3
• Inclusion Criteria:
• • Adult subjects (aged between 65 and 85 years old)
• • Subjects fluent in written and spoken French
• • Subjects agreeing to attend the totality of 4 visits
• • Subjects that have signed the informed consent form
• Exclusion Criteria:
• • Subjects with tachycardia (heart rate at rest \> 120bpm)
• • Subjects with atrial fibrillation
• • Subjects with diabetes
• • Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2)
• • 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
• • Subjects with an arteriovenous fistula
• • Subjects with arm amputations
• • Subjects with the upper arm circumference \> 64 cm
• • Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size)
• • Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm
• • Subjects with the exfoliative skin diseases (limitation due to participant discomfort)
• • Subjects with lymphoedema (limitation due to participant discomfort)