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

Status: Enrolling

Conditions: Hypertension

Treatments: Device: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff; Device: Marketed device used as reference for blood pressure monitoring: double auscultation cuff; Device: Investigational device Aktiia G2C; Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06368206

OBPM_Calfree2024

Details and patient eligibility

About

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.

Enrollment: 85 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoring

Other group

Description:

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).

Treatment:

Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2

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: oscillometric upper-arm cuff

Device: Marketed device used as reference for pulse rate monitoring: pulse finger oximeter

Device: Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff