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)

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

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 Overview

• Status: Recruiting
• Conditions: Hypertension
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 85
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grégoire Wuerzner, Medical Doctor Prof.; Phone Number: +41213140223; Email: gregoire.wuerzner@chuv.ch

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Recruiting
    • CHUV
    • Contact: Grégoire Wuerzner, MD Prof; Phone Number: +41213141131; Email: gregoire.wuerzner@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring; 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).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of study subjects that contribute with analyzable raw data collected	Min 85 study subjects contribute with analyzable raw data collected	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure mean value of differences	The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.	1 hour
Pulse rate root-mean-square error	The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method.	1 hour
Blood pressure standard deviation of differences	The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.	1 hour

Collaborators and Investigators

• Sponsor: Aktiia SA

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 4, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: OBPM_Calfree2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No