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

ConditionHypertension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-85
SponsorAktiia SA

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

330 Participants
are divided into 1 treatment group
Group A: Harmony study cohort1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
24 hours

Secondary outcomes

1

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

Time frame
24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: