CompletedNCT03054688VASTUpdated Jun 15, 2018

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

An interventional study of Somnotouch NIBP in Blood Pressure, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-15.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Diagnostic

Phase: Not applicable
Study type: Interventional
Enrollment: 83
Allocation: Not applicable
Ages: 25 Years and older
Sex: All

Study summary

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

Conditions studied

Blood Pressure

In context

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 25 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Able to give informed consent

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 83 participants (actual)

Study arms

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

Interventions

DeviceSomnotouch NIBP
Somnotouch NIBP in addition to standard blood pressure measurement

What researchers measure

Primary outcomes

Difference in mean 24h systolic blood pressure
Difference in mean 24h systolic blood pressure
Time frame: 24 hours

Study locations

1 site

University Hospital Basel
Basel, Basel City 4051, Switzerland

References and documents

Publications

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. PubMed 30228251 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03054688
Lead sponsor: University Hospital, Basel, Switzerland
Responsible party: Sponsor
First posted: Feb 15, 2017
Start date: Apr 25, 2017
Primary completion: Mar 1, 2018
Completion: Apr 1, 2018
Last update: Jun 15, 2018

Study contacts

Thilo Burkard, MD

principal investigator · University Hospital, Basel, Switzerland

Philipp Krisai, MD

principal investigator · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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