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)

Aktiia SA85 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Investigational device Aktiia G2CDEVICE

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 cuffDEVICE

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 G2DEVICE

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 cuffDEVICE

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 cuffDEVICE

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 oximeterDEVICE

Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CHUV

Lausanne, Switzerland

RECRUITING

Outcomes

Primary Outcomes

Number of study subjects that contribute with analyzable raw data collected

Min 85 study subjects contribute with analyzable raw data collected

Time frame: 1 hour

Secondary Outcomes

Blood pressure mean value of differences

The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.

Time frame: 1 hour

Blood pressure standard deviation of differences

The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.

Time frame: 1 hour

Pulse rate root-mean-square error

The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method.

Time frame: 1 hour

Central Contacts

Grégoire Wuerzner, Medical Doctor Prof.

CONTACT

+41213140223 gregoire.wuerzner@chuv.ch

Data from ClinicalTrials.gov

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