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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)

RecruitingNAAges 21 Years - 85 YearsAllAktiia SA
NCT06368206 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Investigational device Aktiia G2C
  • Marketed device used as reference for blood pressure monitoring: double auscultation cuff
  • Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
  • Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff
  • Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
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Where

1 site
CHUV
Lausanne, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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