Recruiting
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)
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.
ClinicalTrials.gov IDNCT06368206
PhaseNA
Enrollment85
SponsorAktiia SA
Age21 Years
SexALL
Conditions studied
Hypertension
About this study
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.
Interventions
- Device: Investigational device Aktiia G2C — Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.
- Device: Marketed device used as reference for blood pressure monitoring: double auscultation cuff — Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.
- Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2 — Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.
- Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff — Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.
- Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff — Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.
- Device: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter — Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.
Primary outcomes
- Number of study subjects that contribute with analyzable raw data collected (1 hour)
Eligibility information
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
Study locations
- CHUV, Lausanne, 1011 Switzerland
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.