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

Not Applicable

Recruiting

• Conditions: Hypertension

• Registration Number: NCT06698536
• Lead Sponsor: Aktiia SA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Study Start: 2024-12-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 255

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Data set build	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

Trial Locations

Locations (1)

CHUV Service de Néphrologie et d'Hypertension; 🇨🇭 Lausanne, Switzerland