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How to exactly measure lung volumes in healthy subjects and COPD patients, non-invasively


- candidate number28771
- NTR NumberNTR7130
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-apr-2018
- Secondary IDsNL65299.044.18 
- Public TitleHow to exactly measure lung volumes in healthy subjects and COPD patients, non-invasively
- Scientific TitleHow to exactly measure lung volumes in healthy subjects and COPD patients, non-invasively
- ACRONYMThe Hexoskin Study
- hypothesisthe hexoskin shirt can adequately measure lung volumes, compared to the gold standard
- Healt Condition(s) or Problem(s) studiedCOPD, Healthy volunteers
- Inclusion criteriaIn 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 criteriaIn 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 25-sep-2018
- planned closingdate1-mei-2020
- Target number of participants60
- InterventionsN.A.
- Primary outcomeThe 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 outcomerepeatability 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
- Timepoints-
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES D.C. Mannée
- CONTACT for SCIENTIFIC QUERIES D.C. Mannée
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
EFRO, Chiesi Pharmaceuticals
- Publications-
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD5-apr-2018 - 10-dec-2018


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