HypertensionOBPM_HARMONYNCT07099716
OBPM_HARMONY: Physiological Data Recording Over 24 Hours Using the Continual Optical Hilo Blood Pressure Monitor and an Ambulatory Blood Pressure Monitor
An observational study of Hypertension, run by Aktiia SA.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor
- Type of treatment
- Medical device
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2025to 15 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
Read the 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
- Being tested
- Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor
- Keywords
- HARMONY, Hypertension, CHUV
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raw 24-hour data collection using the continual Hilo monitor alongside the Ambulatory Blood Pressure Monitor across minimum 300 study subjects.
Measured: 24 hours
Secondary outcomes (1)
Evaluation of survey results on comfort, usability, and ease of use for both devices
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099716
- Sponsor's protocol ID
- OBPM_HARMONY
- Acronym
- OBPM_HARMONY
- Status last verified
- Sep 2025
- First submitted
- 25 Jul 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07099716
- Acronym / sponsor ID
- OBPM_HARMONY / OBPM_HARMONY
- Conditions
- Hypertension
- Keywords
- HARMONY, Hypertension, CHUV
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Harmony study cohort | – | Device: Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitor24-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 |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing Hilo band, Ambulatory Blood Pressure Monitor, and Hydrostatic Pressure monitorDuring 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. | Device | Harmony study cohort |
Primary outcome
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
1 secondary outcome
Evaluation of survey results on comfort, usability, and ease of use for both devices
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Aktiia SA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grégoire WUERZNER, Prof. Med. (+41 21 314 02 23, gregoire.wuerzner@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.