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)
| NCT ID | NCT06368206 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aktiia SA |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2024-06-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 85 participants in total. It began in 2024-06-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06368206 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06368206 currently recruiting?
Yes, NCT06368206 is actively recruiting participants. Contact the research team at gregoire.wuerzner@chuv.ch for enrollment information.
Where is the NCT06368206 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT06368206 clinical trial?
NCT06368206 is sponsored by Aktiia SA. The trial plans to enroll 85 participants.