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)
Recruiting
N/AInterventional Study
Hypertension
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
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At a Glance
Age
21 – 85
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
85 (estimated)
Sponsor
Aktiia SA · Industry
Who this trial is looking for
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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 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 in…
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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