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Recruiting NCT06698536

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

Trial Parameters

Condition Hypertension
Sponsor Aktiia SA
Study Type INTERVENTIONAL
Phase N/A
Enrollment 255
Sex ALL
Min Age 21 Years
Max Age 85 Years
Start Date 2024-12-20
Completion 2026-12-31
Interventions
Aktiia G2C

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.

Eligibility Criteria

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

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