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)
- Conditions
- Hypertension
- Registration Number
- NCT06368206
- Lead Sponsor
- Aktiia SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 85
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Number of study subjects that contribute with analyzable raw data collected 1 hour Min 85 study subjects contribute with analyzable raw data collected
- Secondary Outcome Measures
Name Time Method Pulse rate root-mean-square error 1 hour The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method.
Blood pressure mean value of differences 1 hour The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.
Blood pressure standard deviation of differences 1 hour The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.
Trial Locations
- Locations (1)
CHUV
🇨🇭Lausanne, Switzerland
CHUV🇨🇭Lausanne, SwitzerlandGrégoire Wuerzner, MD ProfContact+41213141131gregoire.wuerzner@chuv.ch