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 · NCT06368206 · Interventional (participants receive a specific treatment) · Lead sponsor: Aktiia SA
View the official record on ClinicalTrials.gov →Interventions studied
Investigational device Aktiia G2CMarketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuffMarketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuffMarketed device used as reference for blood pressure monitoring: double auscultation cuffMarketed device used as reference for pulse rate monitoring: pulse finger oximeter
What this trial is about
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.
Who can take part
Age range
21 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- CHUV - Lausanne, Switzerland