Temperature Change, BodyTEMP-REC-LUNGNCT05344300
Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases
An observational study of Temperature Change, Body and Bronchiectasis, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body, Bronchiectasis, Heat Exposure
- What is being tested?
- Temperature-measurement in lungs under sauna bath
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2022to Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age ≥ 18 years
- Competent and capable
- Forced expiratory volume in the first second (FEV1)>1,0 L
- Does not suffer from bronchiectasis, asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, sarcoidosis, active lung infection (past 30 days) or lung cancer
- Age ≥ 18 years
- Competent and capable
- FEV1>1,0 L
- Have diagnosed bronchiectasis [radiology verified and evaluated by pulmonary specialist]
Who cannot join
- Allergy to lidocaine and/or midazolam
- Contraindications to bronchoscopy*
- Previous severe laryngospasm (intubation requiring)
- Pregnancy/breastfeeding
- Severe linguistic problems or inability to give informed consent
- Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others
Show all 13Show fewer
- Bronchiectasis group:
- Allergy to lidocaine and/or midazolam
- Contraindications to bronchoscopy*
- Previous severe laryngospasm (intubation requiring)
- Pregnancy/breastfeeding
- Severe linguistic problems or inability to give informed consent
- Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medicine, Section of Respiratory Medicine, Herlev and Gentofte Hospital
Gentofte Municipality, Copenhagen, 2900
About this study
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.
Read the detailed description
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.
- Conditions
- Temperature Change, Body, Bronchiectasis, Heat Exposure, Heat
- Being tested
- Temperature-measurement in lungs under sauna bath
- Medical subject headings
- Body Temperature Changes, Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature-measurement in lungs under sauna bathOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lung-healthy group | Not described Receives: Other: Temperature-measurement in lungs under sauna bath | |
| Bronchiectasis group | Not described Receives: Other: Temperature-measurement in lungs under sauna bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Sep 2022
- Primary completionApr 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344300
- Sponsor's protocol ID
- TEMP-REC-LUNG
- Acronym
- TEMP-REC-LUNG
- Status last verified
- Aug 2023
- First submitted
- 19 Apr 2022
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Recording in Lungs of Volunteers With and Without Pulmonary Diseases
- ClinicalTrials.gov ID
- NCT05344300
- Acronym / sponsor ID
- TEMP-REC-LUNG / TEMP-REC-LUNG
- Conditions
- Temperature Change, Body, Bronchiectasis, Heat Exposure, Heat
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Chronic Obstructive Pulmonary Disease Trial Network, DenmarkUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung-healthy group | – | Other: Temperature-measurement in lungs under sauna bath |
| Bronchiectasis group | – | Other: Temperature-measurement in lungs under sauna bath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Competent and capable
- Forced expiratory volume in the first second (FEV1)>1,0 L
- Does not suffer from bronchiectasis, asthma, chronic obstructive pulmonary disease, pulmonary fibrosis, sarcoidosis, active lung infection (past 30 days) or lung cancer
- Age ≥ 18 years
Key exclusion criteria (13 listed)
- Allergy to lidocaine and/or midazolam
- Contraindications to bronchoscopy*
- Previous severe laryngospasm (intubation requiring)
- Pregnancy/breastfeeding
- Severe linguistic problems or inability to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temperature-measurement in lungs under sauna bathThrough 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. | Other | Bronchiectasis group, Lung-healthy group |
Primary outcome
Changes in air temperature
Time frame: 1 day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temperature Change, Body and Bronchiectasis, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in air temperature (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.