Somnotouch-NIBP Compared to Standard Ambulatory 24-hours... | NCT03975582

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

NCT03975582

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

May 16, 2024Actual

Enrollment

115Actual

Phase

Not provided

Conditions

Blood Pressure

Interventions

Not provided

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

Nov 2023

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

Jul 4, 2019Actual

Primary Completion Date

Feb 28, 2022Actual

Completion Date

Feb 28, 2022Actual

First Submitted Date

Apr 24, 2019

First Submission Date that Met QC Criteria

Jun 3, 2019

First Posted Date

Jun 5, 2019Actual

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

May 14, 2024

Last Update Posted Date

May 16, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Ability to give informed consent

Exclusion Criteria:

Age < 18 years
Medical reasons that forbid blood pressure measurements on upper extremities
Not able to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients from the medical outpatient clinic of the University Hospital of Basel with an indication for an ambulatory 24h blood pressure measurement.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel	Canton of Basel-City	4031	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.