Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement (VAST)

• ClinicalTrials.gov Identifier: NCT03054688
• Recruitment Status: Completed
• First Posted: February 15, 2017
• Last Update Posted: June 15, 2018
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

Tracking Information

• First Submitted Date: February 13, 2017
• First Posted Date: February 15, 2017
• Last Update Posted Date: June 15, 2018
• Actual Study Start Date: April 25, 2017
• Actual Primary Completion Date: March 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2017)

Difference in mean 24h systolic blood pressure [ Time Frame: 24 hours ]

Difference in mean 24h systolic blood pressure

• Original Primary Outcome Measures (submitted: February 13, 2017): Difference in mean 24h systolic blood pressure [ Time Frame: 24 hours ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement
• Official Title: Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement
• Brief Summary: Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Blood Pressure

Intervention

Device: Somnotouch NIBP

Somnotouch NIBP in addition to standard blood pressure measurement

Study Arms

Experimental: Somnotouch NIBP

Blood pressure measurement with Somnotouch-NIBP device in addition to standard cuff based device

Intervention: Device: Somnotouch NIBP

• Publications *: Krisai P, Vischer AS, Kilian L, Meienberg A, Mayr M, Burkard T. Accuracy of 24-hour ambulatory blood pressure monitoring by a novel cuffless device in clinical practice. Heart. 2019 Mar;105(5):399-405. doi: 10.1136/heartjnl-2018-313592. Epub 2018 Sep 18.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2018): 83
• Original Estimated Enrollment (submitted: February 13, 2017): 50
• Actual Study Completion Date: April 1, 2018
• Actual Primary Completion Date: March 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT03054688
• Other Study ID Numbers: 03061989
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University Hospital, Basel, Switzerland
• Original Responsible Party: Thilo Burkard, University Hospital, Basel, Switzerland, Dr. med.
• Current Study Sponsor: University Hospital, Basel, Switzerland
• Original Study Sponsor: Thilo Burkard
• Collaborators: Not Provided

Investigators

• Principal Investigator: Thilo Burkard, MD; University Hospital, Basel, Switzerland
• Principal Investigator: Philipp Krisai, MD; University Hospital, Basel, Switzerland

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: June 2018