An observational study in Temperature Change, Body, Bronchiectasis and Heat Exposure, sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-01.
Sponsored by Chronic Obstructive Pulmonary Disease Trial Network, Denmark · Observational
The purpose of the project is to estimate the air temperature in the lungs after a change from room temperature (25℃) to an environment with a constant temperature of 88-92℃ in resp. lung-healthy persons and persons with bronchiectasis.
Heat is a widely available therapeutic modality and is often used for recovery after physical activity and pain treatment, and sauna bathing is a form of whole body thermotherapy ranging from 80-100 ℃ and low humidity of 10-20%. The heat load in a sauna has been shown to activate several beneficial physiological effects, and no adverse effects on the lungs have been demonstrated. It is unknown how much the air temperature in the lower respiratory tract (bronchial tree) in humans rises to under surroundings of 88-92℃.
This is an observational, clinical trial investigating the changes in air temperature at different bronchial segments in both lungs under surroundings of 88-92℃ resp. in lung-healthy persons and persons with bronchiectasis.
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's planned enrollment of 10 is below the median of 87 across 24 observational studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →Chronic Obstructive Pulmonary Disease Trial Network, Denmark is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Lung-healthy group: 5 persons will be recruited via bulletins in staff rooms and outpatient clinics at participating departments/hospitals.
Bronchiectasis group: 5 patients will be recruited via outpatient clinics at participating departments/hospitals.
Lung-healthy group:
Inclusion criteria:
Exclusion criteria:
Bronchiectasis group:
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Temperature-measurement in lungs under sauna bath
Other: Temperature-measurement in lungs under sauna bath
Through a bronchoscopy procedure under an 88-92℃ environment, the air temperature is measured in the 1st, 2nd and 3rd bronchial segment, at 4th and 5th bronchial segment and at 6th-10th bronchial segment in resp. the right and left lung. The temperature is measured at time: 0 seconds (s), 15 s, 30 s, 45 s, 60 s, 75 s, 90 s, 105 s, 120 s, 135 s and 150 s.
Changes in air temperature
Changes in air temperature (under 88-92℃ surroundings) measured in both lungs at 1st, 2nd and 3rd bronchial segment, at 4th and 5th bronchial segment and at 6th-10th. bronchial segment at times 0 s, 15 s, 30 s, 45 s, 60 s, 75 s, 90 s, 105 s, 120 s, 135 s, and 150 s.
Time frame: 1 day
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Chronic Obstructive Pulmonary Disease Trial Network, Denmark