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Clinical Trials/NCT06368206
NCT06368206
Recruiting
Not Applicable

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

Aktiia SA1 site in 1 country85 target enrollmentJune 25, 2024
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ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
Aktiia SA
Enrollment
85
Locations
1
Primary Endpoint
Number of study subjects that contribute with analyzable raw data collected
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Aktiia SA
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Pulse rate root-mean-square error(1 hour)
  • Blood pressure mean value of differences(1 hour)
  • Blood pressure standard deviation of differences(1 hour)

Study Sites (1)

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