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)

NCT06368206 · tracked via the Priya Life Science Switzerland tracker

Sponsor

Aktiia SA

Phase

Not applicable

Started

2024-06-25

Last updated

2024-12-17

Condition(s) studied

Hypertension

Investigational drug(s) / intervention(s)

Investigational device Aktiia G2CMarketed device used as reference for blood pressure monitoring: double auscultation cuffMarketed 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 pulse rate monitoring: pulse finger oximeter

Investigational device Aktiia G2C: Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia G2C.

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.

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.

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.

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.

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.

Study 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

Sex

ALL

Min age

21 Years

Max age

85 Years

Healthy volunteers

Accepted

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

Primary outcome measure(s)

Number of study subjects that contribute with analyzable raw data collected — 1 hour
Min 85 study subjects contribute with analyzable raw data collected

Trial sites (1)

Facility	City	Region	Status
CHUV	Lausanne	Switzerland	Recruiting

More Aktiia SA trials in Switzerland

Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation Recruiting

OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff Recruiting

OBPM_Meds2023: Multicentric Prospective Clinical Study to Evaluate the Aktiia Optical Blood Pressure Monitoring (OBPM) Device Compared to Standard Home Blood Pressure Monitoring (HBPM) in Hypertensive Patients When Blood Pressure Lowering Medications Intake Recruiting

Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk Recruiting

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The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension Active, not recruiting

OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06368206 on ClinicalTrials.gov ↗ ← All trials in Switzerland