Blood PressureNAMBPNCT04119518
Night Ambulatory Monitoring Of Blood Pressure
A study testing CSEM Pulse Watch in people with Blood Pressure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
To determine accuracy of nightly non occlusive blood pressure measurements by the non-occlusive CSEM Pulse Watch compared to a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor, Spacelabs Healthcare, Washington, USA) internationally validated for the 24h ABPM in Patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure
- What is being tested?
- CSEM Pulse Watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2019to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients > 18y
- Good understanding of written and oral German
- Signed informed consent
- Scheduled for 24h blood pressure exam
Who cannot join
- Patients with unhealthy mental state
- Patients with an active implantable medical device (AIMD)
- Arteriopathy of the upper limbs with/without stenosis
- Severe congestive heart failure (LV-EF ≤25%)
- Sever aortic-valve stenosis mean gradient >40mmHg, valve area <1cm2)
- Congenital heart disease including aortic isthmus stenosis
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- Untreated heart rhythm disorders, heart rate at rest > 120/bpm
- Severe untreated arterial hypertension (BPsyst > 180mmHg, BPdiast > 100mmHg)
- Atrial fibrillation
- Instable angina pectoris
- Malcompliance concerning medication intake
- Active alcohol or drug abuse
- Pregnancy or lactation (women of childbearing age will be asked to performed urinary pregnancy test before the screening phase)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Night Ambulatory Monitoring Of Blood Pressure Clinical Study Protocol
To determine accuracy of nightly non occlusive blood pressure measurements by the non-occlusive CSEM Pulse Watch compared to a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor, Spacelabs Healthcare, Washington, USA) internationally validated for the 24h ABPM in Patients.
Read the detailed description
Elevated Blood Pressure (BP) is a chronic medical condition with a prevalence of about 45% in the middle-aged population.
The particular interest of this project is given to the diagnosis and treatment of so-called nocturnal hypertension. Unfortunately, current monitoring practice relies on the use of occlusive pneumatic cuffs inflated around the arm to assess BP. Based on oscillometric technique, occlusive cuffs perform intermittent BP measurements every 20 minutes, thus providing only a limited view of the BP regulation landscape. In addition, oscillometric measurement performs a full occlusion of the measured arm inducing awakening reactions, and leading to non-representative overestimated BP values. The non-occlusive measurement of BP is thus an unsolved problem of modern medicine.
The aim of the NAMBP (Night Ambulatory Monitoring of Blood Pressure) project is to develop, implement and test in clinical trials a first-ever non-occlusive BP sensor to be used during sleep.
A novel technology for the non-occlusive measurement of BP from photoplethysmographic (optical) signals, known as Pulse Wave Analysis (PWA), has been investigated for the past decade by the Centre Suisse d'Electronique et de Microtechnique (CSEM, Neuchâtel, Switzerland). The herein proposed system - the CSEM Pulse Watch - consists in a single sensor (watch-like device) attached at the wrist that measures photoplethysmographic waveforms induced by the pulsatility of the skin arteries of the wrist. These waveforms are then post-processed via PWA: The system will detect features in the measured waveforms that correlate, through the phenomenon of wave reflections, to the underlying BP of the patient.
- Conditions
- Blood Pressure
- Being tested
- CSEM Pulse Watch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSEM Pulse WatchDevice
Comparison of CSEM Pulse Watch with a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor.
| Study group | Role | What they receive |
|---|---|---|
| Healthy and hypertensive subjects | Other | Subjects will be enrolled to be monitored for 24 hours via: the non-occlusive CSEM Pulse Watch, and a gold standard oscillometric device (Spacelabs OnTrak Ambulatory Blood Pressure monitor, Spacelabs Healthcare, Washington, USA) internationally validated for the 24h ABPM. Receives: Device: CSEM Pulse Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the accuracy
Continuous blood pressure measurement of the novel device will be compared to measurements assessed by a standard 24h blood pressure monitor at normal out of hospital conditions during night periods.
Measured: Day 0 for 24 hours
Secondary outcomes (1)
Assessment of the acceptability
Acceptability of the novel blood pressure device in patients when used during 24 hours will be assessed by means of a questionnaire filled in by patients at day 1. The scale title is: Fragebogen. The minimum value is -1 and the maximum value is 10. The higher score means worse outcome.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Jan 2019
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, method-comparison, proof of concept, single centre study
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Responsible party
- Sponsor
- Investigators
- Emrush Rexhaj, MD, Study director, University Hospital Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119518
- Sponsor's protocol ID
- 2016-00614
- Other IDs
- 2016
- Acronym
- NAMBP
- Status last verified
- Jan 2023
- First submitted
- 4 Oct 2019
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Night Ambulatory Monitoring Of Blood Pressure Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT04119518
- Acronym / sponsor ID
- NAMBP / 2016-00614
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 8 Oct 2019 (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.
To determine accuracy of nightly non occlusive blood pressure measurements by the non-occlusive CSEM Pulse Watch compared to a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor, Spacelabs Healthcare, Washington, USA) internationally validated for the 24h ABPM in Patients.
Detailed description
Elevated Blood Pressure (BP) is a chronic medical condition with a prevalence of about 45% in the middle-aged population.
The particular interest of this project is given to the diagnosis and treatment of so-called nocturnal hypertension. Unfortunately, current monitoring practice relies on the use of occlusive pneumatic cuffs inflated around the arm to assess BP. Based on oscillometric technique, occlusive cuffs perform intermittent BP measurements every 20 minutes, thus providing only a limited view of the BP regulation landscape. In addition, oscillometric measurement performs a full occlusion of the measured arm inducing awakening reactions, and leading to non-representative overestimated BP values. The non-occlusive measurement of BP is thus an unsolved problem of modern medicine.
The aim of the NAMBP (Night Ambulatory Monitoring of Blood Pressure) project is to develop, implement and test in clinical trials a first-ever non-occlusive BP sensor to be used during sleep.
A novel technology for the non-occlusive measurement of BP from photoplethysmographic (optical) signals, known as Pulse Wave Analysis (PWA), has been investigated for the past decade by the Centre Suisse d'Electronique et de Microtechnique (CSEM, Neuchâtel, Switzerland). The herein proposed system - the CSEM Pulse Watch - consists in a single sensor (watch-like device) attached at the wrist that measures photoplethysmographic waveforms induced by the pulsatility of the skin arteries of the wrist. These waveforms are then post-processed via PWA: The system will detect features in the measured waveforms that correlate, through the phenomenon of wave reflections, to the underlying BP of the patient.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, method-comparison, proof of concept, single centre study
| Arm | Type | Receives |
|---|---|---|
| Healthy and hypertensive subjects | Other | Device: CSEM Pulse WatchSubjects will be enrolled to be monitored for 24 hours via: the non-occlusive CSEM Pulse Watch, and a gold standard oscillometric device (Spacelabs OnTrak Ambulatory Blood Pressure monitor, Spacelabs Healthcare, Washington, USA) internationally validated for the 24h ABPM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > 18y
- Good understanding of written and oral German
- Signed informed consent
- Scheduled for 24h blood pressure exam
Key exclusion criteria (13 listed)
- Patients with unhealthy mental state
- Patients with an active implantable medical device (AIMD)
- Arteriopathy of the upper limbs with/without stenosis
- Severe congestive heart failure (LV-EF ≤25%)
- Sever aortic-valve stenosis mean gradient >40mmHg, valve area <1cm2)
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 |
|---|---|---|
| CSEM Pulse WatchComparison of CSEM Pulse Watch with a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor. | Device | Healthy and hypertensive subjects |
Primary outcome
Assessment of the accuracy
Time frame: Day 0 for 24 hours
Continuous blood pressure measurement of the novel device will be compared to measurements assessed by a standard 24h blood pressure monitor at normal out of hospital conditions during night periods.
1 secondary outcome
Assessment of the acceptability
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- 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. This study is not recruiting at the moment.
Emrush Rexhaj, MD study director
University Hospital Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSEM Pulse Watch in people with Blood Pressure, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the accuracy (time frame: Day 0 for 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 26 Jan 2023.