Aktiia OPBM Single-center Prospective Observational Study Against Double Auscultation
ConditionBlood Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorAktiia SA
About this trial
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 double auscultation at the upper arm during four weeks
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Aktiia.product-P0
Treatment groups
355 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Aktiia SA
Lead sponsor
University of Lausanne Hospitals
Collaborator
Source ClinicalTrials.gov