Status:

COMPLETED

Night Ambulatory Monitoring Of Blood Pressure

Lead Sponsor:

Insel Gruppe AG, University Hospital Bern

Collaborating Sponsors:

CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Conditions:

Blood Pressure

Eligibility:

All Genders

18+ years

Phase:

NA

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 Pres...

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 treatme...

Eligibility Criteria

Inclusion

  • Patients \> 18y
  • Good understanding of written and oral German
  • Signed informed consent
  • Scheduled for 24h blood pressure exam

Exclusion

  • 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)

Key Trial Info

Start Date :

January 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 30 2021

Estimated Enrollment :

70 Patients enrolled

Trial Details

Trial ID

NCT04119518

Start Date

January 1 2019

End Date

December 30 2021

Last Update

January 26 2023

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Inselspital

Bern, Switzerland, 3010