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

NCT07099716 | Not Yet Recruiting

• 1 other identifier: OBPM_HARMONY
• Study Type: observational
• Target: 330
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hypertension

Keywords

HARMONY; Hypertension; CHUV

Outcome Measures

Primary Outcomes (1)

• Raw 24-hour data collection using the continual Hilo monitor alongside the Ambulatory Blood Pressure Monitor across minimum 300 study subjects.

  24 hours

Secondary Outcomes (1)

• Evaluation of survey results on comfort, usability, and ease of use for both devices

  24 hours

Study Arms (1)

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

Device: Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor

Interventions

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.

Harmony study cohort

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Subjects that have signed the informed consent form.

You may not qualify if:

• Damaged/injured skin at the right wrist
• Subjects with tachycardia (heart rate at rest \> 120bpm)
• Subjects with atrial fibrillation
• Subjects with diabetes
• Subjects with marked renal dysfunctions
• Subjects with untreated hyper-/hypothyroidism
• Subjects with pheochromocytoma
• Subjects with Raynaud's disease
• Subjects with an arteriovenous fistula
• Subjects with implanted electrical devices, such as cardiac pacemakers or defibrillators
• Subjects with premature ventricular beats
• Subjects with peripheral arterial disease
• Subjects undergoing intravascular therapy or arterio-venous shunt
• Subjects who have received a mastectomy
• Women in known pregnancy or women with pre-eclampsia

Sponsors & Collaborators

• Aktiia SA: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Grégoire WUERZNER, Prof. Med.

CONTACT

+41 21 314 02 23; gregoire.wuerzner@chuv.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 1, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-09