Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement (VAST)
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ClinicalTrials.gov Identifier: NCT03054688 |
Recruitment Status :
Completed
First Posted : February 15, 2017
Last Update Posted : June 15, 2018
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Condition or disease | Intervention/treatment | Phase |
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Blood Pressure | Device: Somnotouch NIBP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 83 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement |
Actual Study Start Date : | April 25, 2017 |
Actual Primary Completion Date : | March 1, 2018 |
Actual Study Completion Date : | April 1, 2018 |
Arm | Intervention/treatment |
---|---|
Experimental: Somnotouch NIBP
Blood pressure measurement with Somnotouch-NIBP device in addition to standard cuff based device
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Device: Somnotouch NIBP
Somnotouch NIBP in addition to standard blood pressure measurement |
- Difference in mean 24h systolic blood pressure [ Time Frame: 24 hours ]Difference in mean 24h systolic blood pressure

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Ages Eligible for Study: | 25 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Able to give informed consent
Exclusion Criteria:
- Atrial fibrillation
- Medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054688
Switzerland | |
University Hospital Basel | |
Basel, Basel City, Switzerland, 4051 |
Principal Investigator: | Thilo Burkard, MD | University Hospital, Basel, Switzerland | |
Principal Investigator: | Philipp Krisai, MD | University Hospital, Basel, Switzerland |
Responsible Party: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT03054688 |
Other Study ID Numbers: |
03061989 |
First Posted: | February 15, 2017 Key Record Dates |
Last Update Posted: | June 15, 2018 |
Last Verified: | June 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |