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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) | Clinical Trials | Clareo Health

RECRUITINGNA

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•Aktiia SA

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

CHUV

Lausanne, Switzerland

Key Dates

Start Date

June 25, 2024

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

December 17, 2024

Enrollment

ESTIMATED participants

Conditions

Hypertension

Interventions

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

DEVICE

Contacts

Grégoire Wuerzner, Medical Doctor Prof.

CONTACT

+41213140223 gregoire.wuerzner@chuv.ch

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

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