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Clinical Usefullness of the Cuffless SOMNOtouch NIBP Device for 24-hour Ambulatory Blood Pressure Measurement

NCT04278001 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-02

No results posted yet for this study

Summary

The SOMNOtouch NIBP is a cuffless device for continuous blood pressure measurement. The device is widely used, but validation for 24-hour ambulatory blood pressure measurement (ABPM) is limited. This study seeks to validate the SOMNOtouch device for use in 24-hour ABMP as compared to a validated oscillometric device for 24-hour ABPM. A total of 60 patients with indication for 24-hour BP measurement will be recruited from our tertiary hypertension Clinic. All included patients will conduct dual 24-hour ABPM with both the SOMNOtouch NIBP and a the oscillometric device. Furthermore, patients will undergo measurement of arterial stiffness with a Sphygmocor device as well as complete a questionaire on device related discomfort.

Conditions

  • Arterial Hypertension

Interventions

DEVICE

Dual 24-hour ABPM

Dual 24-hour ABPM with both the SOMNOtouch NIBP and a validated oscillometric 24-hour ABPM-device (SPACELABS 90217 / 90207).

Sponsors & Collaborators

  • Central Jutland Regional Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2020-02-01
Completion
2020-02-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04278001 on ClinicalTrials.gov