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

Last updated: January 17, 2025
Sponsor: Aktiia SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stress

Vascular Diseases

Circulation Disorders

Treatment

Aktiia G2C

Clinical Study ID

NCT06698536
OBPM_COYOTE2024
  • Ages 21-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Inclusion

Inclusion Criteria:

  • 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.

Exclusion

Exclusion Criteria:

  • Amputated index fingers

  • Damaged/injured skin at index fingers

  • Damaged/injured skin at wrists

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

  • Subjects with atrial fibrillation

  • Subjects with diabetes

  • Subjects with marked renal dysfunctions (eGFR < 30mL/min/1.73 m2)

  • Subjects with untreated hyper-/hypothyroidism

  • Subjects with pheochromocytoma

  • Subjects with Raynaud's disease

  • Subjects with an arteriovenous fistula

  • Women in known pregnancy

  • History of polyneuropathy

Study Design

Total Participants: 255
Treatment Group(s): 1
Primary Treatment: Aktiia G2C
Phase:
Study Start date:
December 20, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CHUV Service de Néphrologie et d'Hypertension

    Lausanne, 1011
    Switzerland

    Active - Recruiting

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