Studies
| Study First Submitted Date | 2019-10-04 |
| Study First Posted Date | 2019-10-08 |
| Last Update Posted Date | 2023-01-26 |
| Start Month Year | January 1, 2019 |
| Primary Completion Month Year | December 30, 2021 |
| Verification Month Year | January 2023 |
| Verification Date | 2023-01-31 |
| Last Update Posted Date | 2023-01-26 |
Detailed Descriptions
| Sequence: | 20787899 |
| 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. |
Facilities
| Sequence: | 200658786 |
| Name | Inselspital |
| City | Bern |
| Zip | 3010 |
| Country | Switzerland |
Conditions
| Sequence: | 52340620 |
| Name | Blood Pressure |
| Downcase Name | blood pressure |
Id Information
| Sequence: | 40279905 |
| Id Source | org_study_id |
| Id Value | 2016-00614 |
Countries
| Sequence: | 42700082 |
| Name | Switzerland |
| Removed | False |
Design Groups
| Sequence: | 55781927 |
| Group Type | Other |
| Title | Healthy and hypertensive subjects |
| Description | 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. |
Interventions
| Sequence: | 52651349 |
| Intervention Type | Device |
| Name | CSEM Pulse Watch |
| Description | Comparison of CSEM Pulse Watch with a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor. |
Design Outcomes
| Sequence: | 178004597 | Sequence: | 178004598 |
| Outcome Type | primary | Outcome Type | secondary |
| Measure | Assessment of the accuracy | Measure | Assessment of the acceptability |
| Time Frame | Day 0 for 24 hours | Time Frame | Day 1 |
| Description | 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. | Description | 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. |
Sponsors
| Sequence: | 48477651 | Sequence: | 48477652 |
| Agency Class | OTHER | Agency Class | INDUSTRY |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | Insel Gruppe AG, University Hospital Bern | Name | CSEM Centre Suisse d’Electronique et de Microtechnique SA – Recherche et Developpement |
Overall Officials
| Sequence: | 29375338 |
| Role | Study Director |
| Name | Emrush Rexhaj, MD |
| Affiliation | University Hospital Inselspital |
Design Group Interventions
| Sequence: | 68378963 |
| Design Group Id | 55781927 |
| Intervention Id | 52651349 |
Eligibilities
| Sequence: | 30863464 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria:
Patients > 18y Exclusion Criteria: Patients with unhealthy mental state |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 253936951 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2019 |
| Actual Duration | 36 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 1 |
| Number Of Secondary Outcomes To Measure | 1 |
Designs
| Sequence: | 30609286 |
| Allocation | N/A |
| Intervention Model | Single Group Assignment |
| Observational Model | |
| Primary Purpose | Other |
| Time Perspective | |
| Masking | None (Open Label) |
| Intervention Model Description | Prospective, method-comparison, proof of concept, single centre study |
Responsible Parties
| Sequence: | 28975824 |
| Responsible Party Type | Sponsor |