To investigate the influence of air temperature and humidity on the occurrence of EILO. A better understanding of the pathophysiologic principles causing EILO could lead to increased sensitivity of CLE testing. New insights in the causes of EILO can…
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The main study parameter is the difference of
occurrence of EILO (defined as Maat sumscore >2) during CLE testing at room
temperature and in cold, dry air.
Secondary outcome
-EILO grade score (Maat score; glottic or supraglottic, grade 1-3)
-Symptoms reported
-Duration until start of symptoms after start of exercise, and duration until
peak dyspnoea
-VAS score: before exercise, at peak level of dyspnoea and 2 minutes after
exercise
-Physiologic measurements: breathing frequency, heart rate, heart rate recovery
time, blood pressure
-EMG measurements of diaphragm before and after exercise
-Respiratory induction plethysmography (RIP) during exercise
-Lung function with in- and expiratory flow volume loops before and at 1, 3, 6
minutes after exercise
-FOT measurements before and after exercise
-Audio-visual recordings: breath sounds, observed breathing pattern
-Max Wattage/kg or maximum running pace
-Questionnaire about perceived symptoms and influence of environmental factors
-Astma control test
Background summary
Exercise induced laryngeal obstruction (EILO) is limiting cause of exertional
dyspnoea, and most common in adolescent athletes. EILO is an inappropriate
closure of the larynx during strenuous physical activity with no obvious
laryngeal pathology at rest. Despite the high prevalence of EILO,
pathophysiology and physiological changes preluding EILO are still poorly
understood. It is suggested that environmental factors such as cold air play a
role in the pathogenesis of EILO (1). EILO can be diagnosed by continuous
laryngoscopy during exercise (CLE), during which patients perform an
incremental exercise test until symptoms occur while the larynx is continuously
visualized. We hypothesize that performing CLE tests in a cold, dry air leads
to a higher number of positive tests than performing CLE tests at room
temperature. Furthermore, we aim to gain a better understanding of the
pathophysiological changes leading up to EILO by collecting detailed
physiological data during CLE tests. A better understanding of factors and
circumstances triggering and preluding EILO can hopefully guide towards
tailored and effective therapeutic options.
Study objective
To investigate the influence of air temperature and humidity on the occurrence
of EILO. A better understanding of the pathophysiologic principles causing EILO
could lead to increased sensitivity of CLE testing. New insights in the causes
of EILO can also lead towards new therapeutic strategies as there is no
evidence based therapy regarding EILO yet.
Study design
This study has a prospective, randomized, cross-over design. Subjects suspected
to have EILO who are planned for a CLE test will be asked to perform one extra
CLE test. One test will take place at room temperature, and one in cold, dry
air (5- 10 dgr C) by using a climate chamber. Patients will be randomized into
two groups. One group first performs the test at room temperature, and the
other group first performs the test in cold, dry air. During the CLE test there
will be extensive monitoring of physiological responses to exercise. Patients
will also be asked to fill in a questionnaire about their symptoms and factors
eliciting dyspnoea.
Intervention
-Cold, dry air by using a climate chamber (5-10 dgrC)
Study burden and risks
The burden of participating in this study involves one extra CLE test compared
to standard care. The test takes about one hour and risks are minimal. Patients
will be asked to fill in a questionnaire about their symptoms and perceived
influence of environmental factors on their symptoms. The extra measurements by
Hexoskin and EMG involve no additional risk, besides a small change of an
allergic reaction to EMG stickers. Therefore latex-free stickers are used).
Both Hexoskin and EMG are only used for data collection and are not acted upon
yet.
A benefit of participating is the possible higher chance to receive a positive
test result. This age group is most suited, since EILO prevalence tends to be
highest amongst adolescents. Risks associated with this study are deemed to be
low
Koningsplein 1
Enschede 7512KZ
NL
Koningsplein 1
Enschede 7512KZ
NL
Listed location countries
Age
Inclusion criteria
-Age 10 to 24 years
-Clinical suspicion of EILO and planned for ECT
-Ability to perform exercise challenge test on treadmill or bike
-Written informed consent of patient and/or parents or legal guardians
Exclusion criteria
-Other severe cardiopulmonary disease
-Baseline FEV1 <70 % of predicted
-Use of long acting bronchodilator agents 24 hours before testing
-Use of short acting bronchodilator agents 8 hours before testing
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL77748.000.21 |