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NCT Number: NCT06698536

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

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.

Recruiting

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV Service de Néphrologie et d'Hypertension

Lausanne, 1011, Switzerland

Location status: Recruiting

Location contact

Grégoire WUERZNER, Prof. Med.

CONTACT

[email protected]

+41 21 314 02 23

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

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).

Primary outcomes

  1. Data set build

    Time frame: Baseline

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Pascale Vermare

CONTACT

[email protected]

+41 32 552 20 52

Sponsors and collaborators

Lead sponsor

Aktiia SA

Industry

Registry information

Official study title

OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff: a Single-center, Prospective Clinical Study

Acronym: COYOTE2024

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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