OBPM_HARMONY: Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood P… (NCT07099716) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
OBPM_HARMONY: Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor
330 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range
21 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Raw 24-hour data collection using the continual Hilo monitor alongside the Ambulatory Blood Pressure Monitor across minimum 300 study subjects.