NCT04278001

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

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

Study Start

First participant enrolled

September 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

1.4 years

First QC Date

February 17, 2020

Last Update Submit

September 29, 2023

Conditions

Arterial Hypertension

Keywords

Ambulatory blood pressure measurement

Outcome Measures

Primary Outcomes (3)

  • Difference in blood pressure averages between SOMNOtouch NIBP and SPACELABS 90217 / 90207 during 24-hour ABPM

    in mmHg

    During 24-hour ABPM

  • Difference in mean systolic blood pressure between SOMNOtouch NIBP and SPACELABS 90217 / 90207 during 24-hour ABPM on the patient level

    Bland Altman plots will be used to evaluate accuracy.

    During 24-hour ABPM

  • Difference in mean diastolic blood pressure between SOMNOtouch NIBP and SPACELABS 90217 / 90207 during 24-hour ABPM on the patient level

    Bland Altman plots will be used to evaluate accuracy.

    During 24-hour ABPM

Secondary Outcomes (3)

  • The impact of aortic augmentation index normalized to a Heart frequency of 75 beats/minute on BP Measurements with either device.

    Aortic augmentation index will be measured prior to 24-hour ABPM.

  • The impact of pulse wave velocity on BP Measurements with either device.

    Pulse Wave velocity will be measured prior to 24-hour ABPM.

  • Patient satisfaction with SOMNOtouch device compared with the oscillometric device.

    Immediately after completion om 24-hour ABPM.

Study Arms (1)

Ambulatory blood pressure measurement

OTHER

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

Device: Dual 24-hour ABPM

Interventions

Dual 24-hour ABPMDEVICE

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

Ambulatory blood pressure measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for ABPM with an automated oscillometric device

You may not qualify if:

  • Known significant arterial abnormalities in the upper extremities
  • Known cardiac arrythmia
  • Upper arm circumference \>16,5" or \<6", or
  • Extreme uncontrolled hypertension (i.e. resting office BP \> 230/140 mmHg).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

  • Nyvad J, Christensen KL, Buus NH, Reinhard M. The cuffless SOMNOtouch NIBP device shows poor agreement with a validated oscillometric device during 24-h ambulatory blood pressure monitoring. J Clin Hypertens (Greenwich). 2021 Jan;23(1):61-70. doi: 10.1111/jch.14135. Epub 2020 Dec 17.

    PMID: 33350030DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
When evaluating data quality from either device, PI will be blinded to corresponding BP of the other device.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 20, 2020

Study Start

September 1, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

October 2, 2023

Record last verified: 2023-09

Locations

DK(1)