Using an optical sensor to monitor blood pressure at the fingertip
Recording of Physiological Data Via an Optical Sensor At the Fingertip Alongside with Double Auscultatory and Pulse Oximetry to Evaluate the Effectiveness of an Optical Blood Pressure Monitoring (OBPM) Algorithm That Requires No Calibration with an External Cuff: a Single-center Prospective Clinical Study
NA · Aktiia SA · NCT06368206
This study is testing a new device that measures blood pressure at the fingertip to see how well it works for different people.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Aktiia SA (industry) |
| Locations | 1 site (Lausanne) |
| Trial ID | NCT06368206 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an optical blood pressure monitoring device by collecting raw optical data from participants using the Aktiia G2C system. A minimum of 85 participants will be involved in a single visit lasting about one hour, during which various reference systems will be used for comparison. The study will include individuals with diverse phenotypes to assess the device's performance across different populations.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 85 who are fluent in French and can commit to the study procedures.
Not a fit: Patients with conditions that affect peripheral perfusion or those with certain cardiac arrhythmias may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and non-invasive method for monitoring blood pressure in patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in non-invasive blood pressure monitoring techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects aged 21 to 85yo * Subjects 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 suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including tachycardia (heart rate at rest \> 120bpm) and atrial fibrillation * Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR \< 30mL/min/1.73 m2), hyper-/hypothyroidism, pheochromocytoma or arteriovenous fistula * Pregnant women * Polyneuropathy
Where this trial is running
Lausanne
- CHUV — Lausanne, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Grégoire Wuerzner, Medical Doctor Prof.
- Email: gregoire.wuerzner@chuv.ch
- Phone: +41213140223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypertension