Observational study of a new wrist blood pressure monitor
Official title: Single-center Prospective Observational Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Double Auscultation
Run by Aktiia SA · NCT04027777 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 85 Years |
| Sex | All |
| Enrollment | 355 (estimated) |
| Sponsor | Aktiia SA Industry-sponsored |
| Locations | 1 site (Lausanne) |
| Status | Recruiting |
| Started | August 6, 2019 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 6, 2026 |
| Trial ID | NCT04027777 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with certain cardiovascular conditions, diabetes, or other specified health issues 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 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.
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 gone: While this approach is innovative, similar studies have shown promise in improving blood pressure monitoring techniques, suggesting potential for success.
Who can join: the full rules
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 it's running
-
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
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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.