Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

85 Participants
are divided into 1 treatment group
Group A: Aktiia G2C and references/ comparators for Blood Pressure and Pulse Rate monitoringOther 6 interventions

Trial outcomes

Primary outcomes

1

Number of study subjects that contribute with analyzable raw data collected

Min 85 study subjects contribute with analyzable raw data collected

Time frame
1 hour

Secondary outcomes

1

Blood pressure mean value of differences

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

Time frame
1 hour
2

Blood pressure standard deviation of differences

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

Time frame
1 hour
3

Pulse rate root-mean-square error

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

Time frame
1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aktiia SA

Lead sponsor

Source ClinicalTrials.gov
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