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 | Recruiting

• 1 other identifier: OBPM_Calfree2024
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of study subjects that contribute with analyzable raw data collected

  Min 85 study subjects contribute with analyzable raw data collected

  1 hour

Secondary Outcomes (3)

• Blood pressure mean value of differences

  1 hour

• Blood pressure standard deviation of differences

  1 hour

• Pulse rate root-mean-square error

  1 hour

Study Arms (1)

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

OTHER

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; 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

Interventions

Investigational device Aktiia G2C DEVICE

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

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

Marketed device used as reference for blood pressure monitoring: double auscultation cuff DEVICE

Study subjects are asked to stay seated and relaxed while successive measurements are taken with cuff for double auscultation.

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

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

Study subjects are asked to stay seated and relaxed while successive measurements are taken with Aktiia Bracelet G2.

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

Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff DEVICE

Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric upper-arm cuff.

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

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

Study subjects are asked to stay seated and relaxed while taking successive measurements with an oscillometric wrist cuff.

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

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

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

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

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aktiia SA: lead

Study Sites (1)

CHUV

Lausanne, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Grégoire Wuerzner, Medical Doctor Prof.

CONTACT

+41213140223; gregoire.wuerzner@chuv.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1 study cohort that will test investigational device (Aktiia G2C) and Blood Pressure and Pulse Rate references.

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 16, 2024
• Study Start: June 25, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)