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)

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368206
• Other study ID #: OBPM_Calfree2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Aktiia SA
• Contact: Grégoire Wuerzner, Medical Doctor Prof.
• Phone: +41213140223
• Email: gregoire.wuerzner[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• Investigational device Aktiia G2C
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 cuff
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 G2
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 cuff
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 cuff
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 oximeter
Study subjects are asked to stay seated and relaxed while successive measurements are taken with pulse finger oximeter.

Locations

Country	Name	City	State
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Aktiia SA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of study subjects that contribute with analyzable raw data collected	Min 85 study subjects contribute with analyzable raw data collected	1 hour
Secondary	Blood pressure mean value of differences	The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.	1 hour
Secondary	Blood pressure standard deviation of differences	The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.	1 hour
Secondary	Pulse rate root-mean-square error	The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method.	1 hour