Night Ambulatory Monitoring Of Blood Pressure

NCT04119518 | Completed DMC

• 1 other identifier: 2016-00614
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of the acceptability

  Day 1

Study Arms (1)

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.

Device: CSEM Pulse Watch

Interventions

CSEM Pulse Watch DEVICE

Comparison of CSEM Pulse Watch with a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor.

Healthy and hypertensive subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement: collaborator

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

Study Officials

• Emrush Rexhaj, MD

  University Hospital Inselspital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, method-comparison, proof of concept, single centre study

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 8, 2019
• Study Start: January 1, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

CH (1)