Status:
RECRUITING
Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
Lead Sponsor:
Aktiia SA
Collaborating Sponsors:
University of Lausanne Hospitals
Conditions:
Blood Pressure
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
Single-centre prospective observational study to validate the performance of the Aktiia SA optical blood pressure monitoring (OBPM) device at the wrist against blood pressure measurements obtained by ...
Detailed Description
According to the World Health Organization, by 2025 hypertension will affect 1.5 billion adults worldwide. Half of the adult population is not diagnosed, and half of the treated population is not at t...
Eligibility Criteria
Inclusion
- ARM1
- 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
- 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
Key Trial Info
Start Date :
August 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
185 Patients enrolled
Trial Details
Trial ID
NCT04027777
Start Date
August 6 2019
End Date
December 31 2024
Last Update
February 1 2024
Active Locations (1)
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1
University of Lausanne Hospitals
Lausanne, Switzerland, 1011