NCT07099716

OBPM_HARMONY: Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor

Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor: a Single-center, Prospective Clinical Study.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 330 (estimated)
• Sponsor: Aktiia SA · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor	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.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-05-15
• Completion: 2026-05-15
• First posted: 2025-08-01
• Last updated: 2025-09-12