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

Not yet recruiting

• Conditions: Hypertension

• Registration Number: NCT07099716
• Lead Sponsor: Aktiia SA

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.

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.

Study Timeline

• Study First Submitted: 2025-07-25
• Study First Submitted QC: 2025-07-25
• Study First Posted: 2025-08-01
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-12
• Study Start: 2025-09-15
• Primary Completion: 2026-05-15
• Study Completion: 2026-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Subjects of unsound mind
• Subjects with upper arm circumference < 22cm or > 42cm
• Subjects with wrist circumference <14cm or > 23cm
• A lateral difference in systolic blood pressure >15 mmHg or diastolic blood pressure >10 mmHg between arms.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Evaluation of survey results on comfort, usability, and ease of use for both devices	24 hours