Healthy subjects and subjects with hypertension
Conditions
Interventions
Group 1: Diagnostic test: ABPMpro (SOMNOmedics)
The cuff-based blood pressure measurement of the ABPMpro device is validated against the dual auscultatory standard blood pressure measurement. The measurements are taken sequentially on the same arm
Sponsors
SOMNOmedics GmbH
Eligibility
Sex/Gender
All
Age
12 Years to 80 Years
Inclusion criteria
Inclusion criteria: subjects from all blood pressure classes, hypertensive subjects only on stable antihypertensive regimen since at least 2 weeks; written informed consent; sinus rhythm
Exclusion criteria
Exclusion criteria: arrhythmia; atrial fibrillation; end-stage renal disease; diabetes with organ damage; arm circumference that exceeds the range for arm cuff used with the ABPM device; pregnancy; if any of the following occurs on the measuring arm: no intact skin on the upper arm, dialysis shunt, surgical wounds or bandages, mastectomy or lymph node removal, lymphedema
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of the blood pressure monitor ABPMpro according to the AAMI / ESH / ISO Universal Standard (ISO 81060-2: 2018). The blood pressure values of a validated and CE-marked auscultatory blood pressure monitor (boso nova S) are compared with the cuff-based ABPMpro (SOMNOmedics) using the same arm sequential method of the AAMI / ESH / ISO Universal Standard (ISO 81060-2: 2018) (time frame 30 min). | — |
Secondary
| Measure | Time frame |
|---|---|
| Accuracy and reliability of continuous blood pressure measurement using the PTT method; Stability over 24 hours; Accuracy under stress (exercise stress testing) | — |
Countries
Germany
Contacts
Public ContactBernhard Roth
Praxis für Hals-Nasen-Ohrenheilkunde
Outcome results
None listed