The main objective of this study is to assess the ability of a wearable measurement system, the Hexoskin smart shirt, to detect and quantify dynamic hyperinflation. Secondary objectives are to determine the optimal measurement procedure and to…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint in this study is the Pearson correlation coefficient between
the Hexoskin smart shirt and the standard devices to detect and quantify
dynamic hyperinflation
Secondary outcome
Furthermore the degree of dynamic hyperinflation that is detected with the
Hexoskin smart shirt expressed either in milliliters or in arbitrary units
is determined. Other outcome parameters are the sensitivity and specificity to
detect dynamic hyperinflation and the usability of the shirt. A possible
correlation between Borg dyspnea scores and the occurence of dynamic
hyperinflation will be assessed as well.
Background summary
COPD is a disease with a high prevalence and high morbidity, mortality and
health care costs. One of the main problems in COPD is unexplained dyspnea,
especially during exercise. In the past years research has focused on
unravelling the process of dynamic hyperinflation, seen as the main cause of
dyspnea at exercise. Research has shown that reduction in dynamic
hyperinflation (DH), can diminish the burden of disease in COPD. However, until
now, no ambulant and continuous monitoring tool is available to detect and
quantify the degree of DH in COPD. In this study the Hexoskin smart shirt,
capable of measuring several cardiopulmonary vital parameters is assessed for
its usability in COPD diagnostics and treatment.
Study objective
The main objective of this study is to assess the ability of a wearable
measurement system, the Hexoskin smart shirt, to detect and quantify dynamic
hyperinflation. Secondary objectives are to determine the optimal measurement
procedure and to assess the accuracy, usability and convenience of the smart
shirt.
Study design
The study will be carried out in two phases. Phase 1 is a cross-sectional pilot
study with fifteen healthy volunteers. Phase 2 is a prospective comparison
study between fifteen COPD patients (with a high likelihood of experiencing
dynamic hyperinflation) and fifteen non-COPD (*healthy*) patients and is
executed in clinical practice.
Intervention
The Hexoskin smart shirt will be applied during several pulmonary function
tests: a standard spirometry procedure, a metronome-paced tachypnea test and an
exercise test. The standard pulmonary function equipment based on flow and
pressure differences is used for comparison of the respiratory parameters such
as tidal breathing and breathing frequency.
Study burden and risks
Subjects in this study will participate during a single visit to the pulmonary
function department. In phase one participation to the tests is estimated to
take about thirty minutes. In phase two the time of testing is estimated to be
fifteen minutes on top of the regular time of the, already planned, lung
function tests. No benefits are related to participating in the study. The
risks of participating in this study are negligible.
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
Healthy subjects:
- Adult, volunteers;Patient group:
- Patients with COPD (GOLD I-IV) that receive planned pulmonary function testing including spirometry and a form of exercise testing (6 minute walk test and/or cardiopulmonary exercise test (CPET)).
- Patients with the clinical suspicion of hyperinflation based on the expert*s opinion. For example a barrel -shaped thorax or Hoover sign during physical examination, or a known increased resting volume (RV) present in spirometry data.;Control group:
- Patients who do not have a clinically defined COPD phenotype and do not have an outflow obstruction (No decrease in the Tiffenau index).
- Patients that receive the same planned pulmonary function tests as the patient group.
Exclusion criteria
- An exacerbation of COPD with hospital admission in four weeks prior to inclusiondate.
- Other associated disease (heart, neurological, rheumatic, or orthopedic).
- Physical impairments causing any disability to perform a physical task
- Inability to read, understand or speak Dutch
- Subjects who do not fit into one of the available sensor shirts
- Subjects with a pacemaker / Implantable cardioverter-defibrillator (ICD) device
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL56190.044.15 |
| OMON | NL-OMON21984 |