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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.
The OBPM_HARMONY study will enroll a minimum of N= 300 participants. Each participant will complete two visits at the CHUV site in Lausanne, Switzerland: Visit 1 (~40 minutes) and Visit 2 (~15 minutes), spaced at least 24.5 hours apart. During Visit 1, participants are equipped with three devices- the Device Under Test (Hilo band), the reference device (Ambulatory Blood Pressure Monitor), worn on the opposite arm, and a hydrostatic pressure system 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 and complete a feedback survey regarding their experience using the Hilo band and the ABPM reference.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmony study cohort | 24-hour Blood Pressure and Heart Rate monitoring with Hilo Band and Ambulatory Blood Pressure Monitor, in parallel of a 24-hour hydrostatic pressure monitoring for the same period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor | Device | During 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Raw 24-hour data collection using the continual Hilo monitor alongside the Ambulatory Blood Pressure Monitor across minimum 300 study subjects. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of survey results on comfort, usability, and ease of use for both devices | 24 hours |
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Inclusion Criteria:
Exclusion Criteria
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grégoire WUERZNER, Prof. Med. | Contact | +41 21 314 02 23 | gregoire.wuerzner@chuv.ch |
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|
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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