Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours... | NCT03054688

Studies
Somnotouch-NIBP Compared to Standard Ambulatory 24 Hours Blood Pressure Measurement

NCT03054688

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Jun 15, 2018Actual

Enrollment

83Actual

Phase

Not Applicable

Conditions

Blood Pressure

Interventions

Somnotouch NIBP

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2017Actual

Primary Completion Date

Mar 1, 2018Actual

Completion Date

Apr 1, 2018Actual

First Submitted Date

Feb 13, 2017

First Submission Date that Met QC Criteria

Feb 13, 2017

First Posted Date

Feb 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2018

Last Update Posted Date

Jun 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Somnotouch NIBP	Experimental	Blood pressure measurement with Somnotouch-NIBP device in addition to standard cuff based device	Device: Somnotouch NIBP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Somnotouch NIBP	Device	Somnotouch NIBP in addition to standard blood pressure measurement	Somnotouch NIBP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in mean 24h systolic blood pressure	Difference in mean 24h systolic blood pressure	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thilo Burkard, MD	University Hospital, Basel, Switzerland	Principal Investigator
Philipp Krisai, MD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel	Canton of Basel-City	4051	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38288945	Derived	Derendinger FC, Vischer AS, Krisai P, Socrates T, Schumacher C, Mayr M, Burkard T. Ability of a 24-h ambulatory cuffless blood pressure monitoring device to track blood pressure changes in clinical practice. J Hypertens. 2024 Apr 1;42(4):662-671. doi: 10.1097/HJH.0000000000003667. Epub 2024 Jan 23.
30228251	Derived