the hexoskin shirt can adequately measure lung volumes, compared to the gold standard
ID
Bron
Verkorte titel
Aandoening
healthy and COPD
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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.
Doel van het onderzoek
the hexoskin shirt can adequately measure lung volumes, compared to the gold standard
Onderzoeksopzet
-
Onderzoeksproduct en/of interventie
N.A.
Publiek
D.C. Mannée
Groesbeek 6561 KE
The Netherlands
+31 (0) 6 15 43 33 75
denise.mannee@radboudumc.nl
Wetenschappelijk
D.C. Mannée
Groesbeek 6561 KE
The Netherlands
+31 (0) 6 15 43 33 75
denise.mannee@radboudumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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%).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6934 |
| NTR-old | NTR7130 |
| CCMO | NL65299.044.18 |
| OMON | NL-OMON50486 |