NCT03054688

Brief Summary

Comparison of 24 hours blood pressure measurement with puls-transit time versus cuffs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

February 13, 2017

Last Update Submit

June 13, 2018

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Difference in mean 24h systolic blood pressure

    Difference in mean 24h systolic blood pressure

    24 hours

Study Arms (1)

Somnotouch NIBP

EXPERIMENTAL

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

Device: Somnotouch NIBP

Interventions

Somnotouch NIBPDEVICE

Somnotouch NIBP in addition to standard blood pressure measurement

Somnotouch NIBP

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give informed consent

You may not qualify if:

  • Atrial fibrillation
  • Medical reasons why blood pressure measurement is not possible at the upper extremity (Shunt, Lymphedema)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4051, Switzerland

Location

Related Publications (2)

  • 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.

    PMID: 38288945DERIVED

  • 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.

    PMID: 30228251DERIVED

Study Officials

  • Thilo Burkard, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

  • Philipp Krisai, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 15, 2017

Study Start

April 25, 2017

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

June 15, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)