About this trial
The OBPM\_HARMONY study will enroll a minimum of 300 participants at the CHUV site in Lausanne, Switzerland. Each participant will complete two study visits at CHUV, scheduled at least 24.5 hours apart. Between these visits, participants will be asked to wear both the Hilo band, an Ambulatory Blood Pressure Monitor (ABPM) as well as a hydrostatic pressure system continuously for a 24-hour period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects aged 21 to 85yo
Subjects fluent in written and spoken French, capable of discernment
Subjects agreeing to attend the two study visits and follow study procedures
Subjects residing within 100 km of the CHUV site
Disqualifiers
Damaged/injured skin at the right wrist
Subjects with tachycardia (heart rate at rest > 120bpm)
Subjects with atrial fibrillation
Subjects with diabetes
Trial population
Any patients attending the Nephrology and Hypertension Department at CHUV in Lausanne, Switzerland, for a consultation who, as part of their routine clinical care, require an Ambulatory Blood Pressure Monitor placement and meet the study's eligibility criteria.
Trial design
Other
Prospective
Treatments tested in this trial
Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor
DeviceDuring study Visit 1, participants are equipped with tthree devices- the Device Under Test (Hilo band), the reference device (Ambulatory Blood Pressure Monitor), worn on the opposite arm, and a Hydrostatic pressure monitor on the chest. Subjects are instructed to wear the three devices for the next 24 hours to collect blood pressure (BP) and heart rate (HR) data as well as hydrostatic pressure measurements. After Visit 1, subjects return home with the devices in place. Visit 2 takes place at least 24.5 hours later, when participants return to the site to hand back the equipment.
Treatment groups
Trial outcomes
Primary outcomes
Raw 24-hour data collection using the continual Hilo monitor alongside the Ambulatory Blood Pressure Monitor across minimum 300 study subjects.
Secondary outcomes
Evaluation of survey results on comfort, usability, and ease of use for both devices
Locations
This trial is not recruiting at the moment. You can still explore other options: