OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff

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

About this trial

The present study, OBPM\_COYOTE2024, with N = 255 participants minimum over 1 visit (lasting \~15min), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational device together with Aktiia G2 Bracelet and Aktiia Init I1 oscillometric cuff within a cohort of subjects characterized by a wide variety of phenotypes. The resulting dataset will support research and development activities conducted by AKTIIA SA out of the study context.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects aged 21 to 85yo

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Aktiia G2C

    Device

    Study subjects are asked to stay seated while 3 successive measurements are taken with the Aktiia G2C device under investigation (BP and PR) and two references (Aktiia Bracelet G2 and Aktiia Init I1 oscillometric cuff).

Treatment groups

255 Participants
are divided into 1 treatment group
Group A: Aktiia G2C cohortOther 1 intervention

Trial outcomes

Primary outcomes

1

Data set build

Number of subjects including three assessments of blood pressure using Aktiia G2C Clinical, alongside three assessments of blood pressure with Aktiia Bracelet G2 and three values of blood pressure generated with the Aktiia Init I1 oscillometric cuff

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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