OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aktiia G2C.
- Who it may be relevant to
- Registry conditions: Hypertension. Basic parameters: 21 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Device Aktiia G2C
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 outcome measures
- Data set build [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Switzerland · 1 center
- CHUV Service de Néphrologie et d'Hypertension — Lausanne
Identifiers
NCT: NCT06698536 · OBPM_COYOTE2024