Night Ambulatory Monitoring Of Blood Pressure (NAMBP)
Night Ambulatory Monitoring Of Blood Pressure Clinical Study Protocol
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bern, Switzerland, 3010
- Inselspital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients > 18y
- Good understanding of written and oral German
- Signed informed consent
- Scheduled for 24h blood pressure exam
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Healthy and hypertensive subjects
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.
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Comparison of CSEM Pulse Watch with a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of the accuracy
Time Frame: Day 0 for 24 hours
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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.
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Day 0 for 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of the acceptability
Time Frame: Day 1
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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.
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Day 1
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Emrush Rexhaj, MD, University Hospital Inselspital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2016-00614
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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