No registrations found.
ID
Source
Brief title
Health condition
healthy and COPD
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter will answer the main objective, can the Hexoskin shirt accurately measure volume relative to the gold standard (spirometer or Oxycon Mobile). This analysis is performed in healthy subjects and later on in COPD patients. The Bland-Altman plot will be plotted as a percentage instead of a absolute difference. And is calculated with: ((volumes Method A – volumes Method B) / mean volumes of both methods x 100%), in which Method A is the Hexoskin shirt and Method B spirometer or Oxycon Mobile
Secondary outcome
repeatability of measurements in two sessions (ICC)
effects of position and activity on the measurements with the Hexoskin (t-tests)
bias calculated with the Bland-Altman plots
Percentage error in volumes between Hexoskin shirt and gold standard
experience of the subjects with the Hexoskin shirt
Background summary
In this study a non-invasive and continuous monitoring wearable, the Hexoskin shirt (with respiratory inductance plethysmography sensors), will be tested on its reproducibility, repeatability and reliability to measure lung volumes and dynamic hyperinflation (DH). The primary objective is to investigate the accuracy of the volumes measured by the Hexoskin shirt relative to a (mobile) spirometer in healthy subjects and in patients with chronic obstructive pulmonary disease. Secondary objective are to determine repeatability of the Hexoskin shirt measurement, the correlation with spirometer, effects of position and activity, reliability of the Hexoskin shirt to measure DH and to investigate the subjects experience with the Hexoskin shirt.
Study objective
the hexoskin shirt can adequately measure lung volumes, compared to the gold standard
Study design
-
Intervention
N.A.
D.C. Mannée
Groesbeek 6561 KE
The Netherlands
+31 (0) 6 15 43 33 75
denise.mannee@radboudumc.nl
D.C. Mannée
Groesbeek 6561 KE
The Netherlands
+31 (0) 6 15 43 33 75
denise.mannee@radboudumc.nl
Inclusion criteria
In part 1, thirty healthy subject between 18-80 years are included, after signing informed consent. All subjects have a normal lung function (forced expiratory volume in 1 second (FEV1) > 80%).
Exclusion criteria
In part 2, thirty COPD patients are included. All subjects have a lung function with FEV1 < 80%, corresponding to GOLD stage II-IV. Exclusion criteria, for both parts of the study, are physical impairment to perform physical tests, not fitting an available shirt, presence of a pacemaker or implantable cardioverter defibrillator, inability to read/understand Dutch language. And for COPD patients, an exacerbation within 1 month before inclusion is a exclusion criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6934 |
| NTR-old | NTR7130 |
| CCMO | NL65299.044.18 |
| OMON | NL-OMON50486 |