Health TrialsbyHealthPanel

Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation

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

About this trial

Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by double auscultation at the upper arm during four weeks

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult subjects (aged between 21 and 65 years old)

Subjects fluent in written and spoken French

Subjects agreeing to attend the totality of 4 visits

Subjects that have signed the informed consent form

Disqualifiers

Subjects with tachycardia (heart rate at rest > 120bpm)

Subjects with atrial fibrillation

Subjects with diabetes

Subjects with renal dysfunctions (eGFR < 60mL/min/1.73 m2)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aktiia.product-P0

    Device

    The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously.

Treatment groups

355 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Aktiia.product-P0Experimental treatment 1 intervention
Group B: Aktiia.product-P0 DiabeticsExperimental treatment 1 intervention
Group C: Aktiia.product-P0 AgedExperimental treatment 1 intervention
Group D: Aktiia.product-P0 and subjects with Chronic Kidney diseaseExperimental treatment 1 intervention
Group E: Aktiia.product-P0 and subjects with Heart FailureExperimental treatment 1 intervention
Group F: Aktiia.product-P0 and Pregnant subjectsExperimental treatment 1 intervention
Group G: Aktiia.product-P0 and subjects in Post partumExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Blood Pressure absolute Mean Error

The absolute value of the mean of the differences between Reference and Aktiia.product-P0 blood pressure determinations

Time frame
Up to four weeks
2

Blood Pressure standard Deviation of the Error

The standard deviation of the differences between Reference and Aktiia.product-P0 determinations

Time frame
Up to four weeks

Secondary outcomes

1

Heart Rate root-mean-square error

The root-mean-square difference between the Aktiia.product-P0 heart rate determinations and the Reference method

Time frame
Up to four weeks

Other outcomes

Sponsors and contacts

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

Aktiia SA

Lead sponsor

University of Lausanne Hospitals

Collaborator

Source ClinicalTrials.gov
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