Health Trials

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)

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorAktiia SA

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Investigational device Aktiia G2C
  • Marketed device used as reference for blood pressure monitoring: double auscultation cuff
  • Marketed device used as comparative device for blood pressure and pulse rate monitoring: Aktiia Bracelet G2
  • Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric upper-arm cuff
  • Marketed device used as comparative device for blood pressure and pulse rate monitoring: oscillometric wrist cuff
  • Marketed device used as reference for pulse rate monitoring: pulse finger oximeter

Treatment groups

85 Participants
are divided into 1 treatment group

Sponsors and collaborators

Aktiia SA

Lead sponsor

Source ClinicalTrials.gov