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NCT Number: NCT06368206

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)

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Investigational device Aktiia G2C

Device

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

Device

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

Device

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

Device

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

Device

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

Device

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

Primary outcomes

  1. Number of study subjects that contribute with analyzable raw data collected

    Time frame: 1 hour

    Min 85 study subjects contribute with analyzable raw data collected

Secondary outcomes

  1. Blood pressure mean value of differences

    Time frame: 1 hour

    The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.

  2. Blood pressure standard deviation of differences

    Time frame: 1 hour

    The mean value of the differences between Aktiia G2C and double auscultation blood pressure measurements.

  3. Pulse rate root-mean-square error

    Time frame: 1 hour

    The root-mean-square difference between the Aktiia G2C pulse rate determinations and the reference method.

Study contacts

Contact information is provided by the study sponsor or research team.

Grégoire Wuerzner, Medical Doctor Prof.

CONTACT

[email protected]

+41213140223

Sponsors and collaborators

Lead sponsor

Aktiia SA

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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