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) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
| Registry | NCT06368206 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, other |
| Enrollment | 85 (Estimated) |
| Sponsor | Aktiia SA (Industry) |
| Conditions | Hypertension |
| Interventions | 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, Marketed device used as reference for pulse rate monitoring: pulse finger oximeter (Device) |
| Dates | start 2024-06-25, primary completion 2025-12-31 (estimated), completion 2025-12-31 (estimated), first posted 2024-04-16, last updated 2024-12-17 |
| Locations | 1 site in Switzerland |
Related Papers Related Patents Related Grants Related Experts
All trials for Hypertension All trials of Investigational device Aktiia G2C All trials of Marketed device used as reference for blood pressure monitoring: double auscultation cuff
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring | Other | Device: Investigational device Aktiia G2C; Device: Marketed device used as reference for blood pressure monitoring: double auscultation cuff; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff; Device: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter | All study participants will test the investigational device (Aktiia G2C) and other marketed devices for blood pressure and pulse rate measurements (Aktiia Bracelet G2, Double auscultation, oscillometric monitors, finger pulse oximeter). |
Sex: All, ages: 21 Years to 85 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| CHUV | Lausanne | Switzerland | Recruiting |