Testing a new wrist blood pressure monitor against traditional methods
Single-center Prospective Clinical Trial to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
This study is testing a new wrist blood pressure monitor to see if it works as well as traditional methods for measuring blood pressure during different activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Aktiia SA Industry-sponsored |
| Locations | 1 site (Lausanne) |
| Trial ID | NCT05236348 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves 225 participants and aims to evaluate the accuracy of the Aktiia optical blood pressure monitoring device compared to traditional double auscultation methods. Participants will engage in various physical activities to simulate real-life scenarios and induce changes in blood pressure. The study will also assess heart rate measurements from the Aktiia device against those from a finger pulse oximeter. Data will be collected over nine visits to ensure a comprehensive assessment of the device's performance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 85 who can read and speak French and are capable of performing simple physical exercises.
Not a fit: Patients with certain cardiovascular conditions, diabetes, or other specified health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and convenient method for monitoring blood pressure at home, potentially improving hypertension management.
How similar studies have performed: Other studies have shown promise in using innovative blood pressure monitoring technologies, but the specific approach of this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult subjects (aged between 21 and 85 years old) * Subjects can read and speak French * Subjects can perform simple physical exercises * Subjects agreeing to attend the totality of 9 visits * Subjects that have signed the informed consent form Exclusion Criteria: * Clinical staff collaborating with study PI * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions * Subjects with hyper-/hypothyroidism * Subjects with pheochromocytoma * Subjects with Raynaud's disease * Subjects with trembling and shivering * Subjects with interarm systolic difference \> 15 mmHg * Subjects with interarm diastolic difference \> 10 mmHg * Subjects with arm paralysis * Women in known pregnancy (for ARM 1 only) * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \< 22cm or \> 42 cm * Subjects with the wrist circumference \> 21 cm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema
Where this trial is running
Lausanne
- University of Lausanne Hospitals — Lausanne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Gregoire Wuerzner, MD — Service of Nephrology and Hypertension CHUV
- Study coordinator: Josep Sola, PhD
- Email: josep@aktiia.com
- Phone: +41797689800
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.