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)

Not Applicable

Recruiting

• Conditions: Hypertension
• Interventions: Device: Investigational device Aktiia G2C

• 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

Study Timeline

• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Study Start: 2024-06-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 85

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring	Investigational device Aktiia G2C	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).

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