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Recruiting NCT06368206

Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM)

Trial Parameters

Condition Hypertension
Sponsor Aktiia SA
Study Type INTERVENTIONAL
Phase N/A
Enrollment 85
Sex ALL
Min Age 21 Years
Max Age 85 Years
Start Date 2024-06-25
Completion 2025-12-31
Interventions
Investigational device Aktiia G2CMarketed device used as reference for blood pressure monitoring: double auscultation cuffMarketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2

Brief Summary

The present study, OBPM\_Calfree2024, with N = 85 participants minimum over 1 visit (lasting around 1h), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational system together with several reference systems within a cohort of subjects characterized by a wide variety of phenotypes.

Eligibility Criteria

Inclusion Criteria: * Subjects aged 21 to 85yo * Subjects fluent in written and spoken French * Subjects agreeing to attend the study visit and follow study procedures * Subjects that have signed the informed consent form. Exclusion Criteria: * Amputated index fingers * Damaged/injured skin at index fingers * Damaged/injured skin at wrists * Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation * Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula * Pregnant women * Polyneuropathy

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