Observational study of a new wrist blood pressure monitor
Single-center Prospective Observational Study 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 upper arm monitors for people managing high blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 355 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Aktiia SA Industry-sponsored |
| Locations | 1 site (Lausanne) |
| Trial ID | NCT04027777 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the performance of the Aktiia optical blood pressure monitoring device, which is worn on the wrist, against traditional blood pressure measurements taken at the upper arm using double auscultation. Over a four-week period, participants will have their blood pressure monitored using this innovative cuffless device, which utilizes optical sensors to measure blood pressure and heart rate. The goal is to assess the accuracy and comfort of this new method compared to conventional techniques, potentially improving hypertension management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 21 to 65 who are fluent in French and can commit to attending all study visits.
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 comfortable and accurate method for monitoring blood pressure, benefiting patients with hypertension.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving blood pressure monitoring techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
ARM1 Inclusion Criteria: * Adult subjects (aged between 21 and 65 years old) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects that have signed the informed consent form Exclusion Criteria: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * 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 * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size) * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases (limitation due to participant discomfort) * Subjects with lymphoedema (limitation due to participant discomfort) ARM2 Inclusion Criteria: * Adult subjects (aged between 21 and 65 years old) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects that have signed the informed consent form Exclusion Criteria: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * 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 * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size) * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases (limitation due to participant discomfort) * Subjects with lymphoedema (limitation due to participant discomfort) ARM3 Inclusion Criteria: * Adult subjects (aged between 65 and 85 years old) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects that have signed the informed consent form Exclusion Criteria: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * 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 * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 22 cm (limitation due Aktiia.bracelet-P0 size) * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases (limitation due to participant discomfort) * Subjects with lymphoedema (limitation due to participant discomfort) ARM 4 The study arm will include: * Adult subjects aged between 21 and 85 years old * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site * Subjects able to pedal with an ergocycle * Subjects that have signed the informed consent form The study will exclude: * Subjects undergoing dialysis treatment * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with untreated 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 * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 5 The study arm will include: * Adult subjects aged between 21 and 85 years old * Subjects with chronic systolic heart failure (Heart Failure with reduce Ejection Fraction), defined by a left ventricular ejection fraction (LVEF) of less than or equal to 40%, confirmed by Echocardiography or MRI * Subjects fluent in written and spoken French Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site * Subjects able to pedal with an ergocycle * Subjects that have signed the informed consent form The study will exclude: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects with untreated 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 * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 6 The study arm will include: * Subjects who are adult females aged 21 years or older * Subjects who are pregnant beyond the first trimester, with a gestational age of more than 12 weeks, confirmed by documentation from a gynecologist * Subjects not requiring hospitalization * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site. * Subjects that have signed the informed consent form The study will exclude: * Subjects with tachycardia (heart rate at rest \> 120bpm * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects with untreated hyper/hypotyroidism not related to pregnancy changes * 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 * Subjects with an arteriovenous fistula * Subjects with arm amputations * Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * Subjects with the exfoliative skin diseases * Subjects with lymphoedema ARM 7 The study arm will include: * Subjects who are adult females aged 21 years or older * Subjects who are postpartum, defined as having given birth within the last 6 weeks and not currently pregnant * Subjects fluent in written and spoken French * Subjects agreeing to attend the totality of 4 visits * Subjects residing within 100 km of the CHUV site. * Subjects that have signed the informed consent form The study will exclude: * Subjects with tachycardia (heart rate at rest \> 120bpm) * Subjects with atrial fibrillation * Subjects with diabetes * Subjects with renal dysfunctions (eGFR \< 60mL/min/1.73 m2) * Subjects with untreated 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 * Subjects with an arteriovenous fistula * Subjects with arm amputations Subjects with the upper arm circumference \> 64 cm * Subjects with the wrist circumference \> 23 cm * Subjects with the central phalanx of the middle finger circumference \> 71 mm or \< 43 mm * 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 — 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.
Conditions
Blood Pressure
Last reviewed 2026-06-13 by the Find a Trial editorial team.
Information on this page is for educational purposes and is not medical advice.
Always consult qualified healthcare professionals about clinical trial participation.