Recording physiological data for hypertension management using new devices
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
Run by Aktiia SA · NCT06698536 · Data updated 2026-11-12
This study is testing new devices to see if they can help collect better data for managing high blood pressure in a diverse group of people.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 85 Years |
| Sex | All |
| Enrollment | 255 (estimated) |
| Sponsor | Aktiia SA Industry-sponsored |
| Locations | 1 site (Lausanne) |
| Status | Recruiting |
| Started | December 20, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 14, 2025 |
| Trial ID | NCT06698536 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 21 to 85 who can communicate in French and are willing to participate in the study.
✕Probably not a fit
Patients with certain conditions such as diabetes, atrial fibrillation, or significant renal dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to collect raw optical data using the Aktiia G2C device, along with the Aktiia G2 Bracelet and oscillometric cuff, to assess hypertension in a diverse group of participants. A minimum of 255 individuals will participate in a single 15-minute visit to gather data that will support further research and development by Aktiia SA. The study focuses on capturing physiological data without the need for calibration, which could enhance the accuracy of hypertension monitoring.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for monitoring and managing hypertension, potentially enhancing patient outcomes.
How similar studies have gone: While this approach is innovative, similar studies have shown promise in improving hypertension monitoring techniques.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CHUV Service de Néphrologie et d'Hypertension
Lausanne, Switzerland Recruiting
Study contacts
- Study coordinator: Pascale Vermare
- Email: pascale.vermare@aktiia.com
- Phone: +41 32 552 20 52
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.