NCT05236348 Performance of the Aktiia Optical Blood Pressure Monitoring Device Against Double Auscultation
| NCT ID | NCT05236348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aktiia SA |
| Condition | Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2022-01-11 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2022-01-11 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study with N = 225 participants (1 cohort of a minimum of 85 and maximum of 140 participants, and an additional cohort with 85 participants) over 9 visits has been designed to assess the accuracy of Aktiia.product-us systolic and diastolic blood pressure measurements against double-auscultation reference measurements. In order to induce blood pressure changes and to simulate ambulatory scenarios, the study participants will be asked to perform a set of activities, involving body position changes and physical exercises. Additionally, this study will compare the heart rate measured by Aktiia.product-us against the reference readings provided by a finger pulse oximeter (as per ISO80601-2-61). The reliability of the auscultation readings will be controlled with simultaneous volume-clamp measurements.
Eligibility 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
Contact & Investigator
Gregoire Wuerzner, MD
PRINCIPAL INVESTIGATOR
Service of Nephrology and Hypertension CHUV
Frequently Asked Questions
Who can join the NCT05236348 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05236348 currently recruiting?
Yes, NCT05236348 is actively recruiting participants. Contact the research team at josep@aktiia.com for enrollment information.
Where is the NCT05236348 trial being conducted?
This trial is being conducted at Lausanne, Switzerland.
Who is sponsoring the NCT05236348 clinical trial?
NCT05236348 is sponsored by Aktiia SA. The principal investigator is Gregoire Wuerzner, MD at Service of Nephrology and Hypertension CHUV. The trial plans to enroll 225 participants.