Clinical trial NCT04119518: Night Ambulatory Monitoring Of Blood Pressure
Official title: Night Ambulatory Monitoring Of Blood Pressure Clinical Study Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
First posted: 2019-10-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, method-comparison, proof of concept, single centre study
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of the accuracy
timeFrame: Day 0 for 24 hours
Secondary outcomes:
measure: Assessment of the acceptability
timeFrame: Day 1
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: University Hospital Inselspital
name: Emrush Rexhaj, MD
role: STUDY_DIRECTOR
References: