Night Ambulatory Monitoring Of Blood Pressure (NAMBP)

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: CSEM Pulse Watch

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: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: CSEM Pulse Watch; Comparison of CSEM Pulse Watch with a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 for 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement
• Investigators: Study Director: Emrush Rexhaj, MD, University Hospital Inselspital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

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)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No