Lung FunctionNCT06652932
Acute Effects of Low Temperature Exposure on Respiratory System
A study testing Low temperature (15°C) group and Moderate temperature (22°C) group in people with Lung Function, run by Fudan University at 1 site in China.
Trial summary
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on respiratory health and the underlying mechanisms. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Function
- What is being tested?
- Low temperature (15°C) group and Moderate temperature (22°C) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 16 Oct 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living in Shanghai during the study period;
- Body mass index > 18.5 and ≤ 28;
- right-handed;
- receiving or having received higher education;
- with the ability to read and understand Chinese smoothly.
Who cannot join
- Smoking and alcohol abuse;
- Current drug and dietary supplements intake;
- Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
- Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
- Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
- Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
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- Subjects who have a history of major surgery due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases;
- Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia;
- Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
- Subjects with color vision disabilities.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Acute Effects of Low Temperature Exposure on Respiratory Health in Healthy Young Adults: A Randomized Controlled Study
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on respiratory health and the underlying mechanisms.
Read the detailed description
The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include lung function tests and exhaled breath test. Investigators plan to collect blood, pharyngeal secretion, exhaled breath condensate and urine samples.
- Conditions
- Lung Function
- Being tested
- Low temperature (15°C) group, Moderate temperature (22°C) group
- Keywords
- Low temperature, Randomized controlled trial, Lung function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low temperature (15°C) groupOther
The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods.
Moderate temperature (22°C) groupOther
The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.
| Study group | Role | What they receive |
|---|---|---|
| Low temperature (15℃) group | Experimental | Subjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber. Receives: Other: Low temperature (15°C) group |
| Moderate temperature (22℃) group | Experimental | Subjects in the exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber. Receives: Other: Moderate temperature (22°C) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of forced expiratory volume in the first second (FEV1)
Investigators plan to measure the changes of the forced expiratory volume in 1 s (FEV1) using a smart spirometer (Model A1, BreathHome, China) supervised by professional medical staff. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion. FEV1 reflect pulmonary function.
Measured: The tests will be conducted at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Changes of forced vital capacity (FVC)
Investigators plan to measure the changes of forced vital capacity (FVC) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). FVC reflects the expiratory resistance of large airways.
Measured: FVC will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Changes of peak expiratory flow rate (PEF)
Investigators plan to measure the changes of peak expiratory flow (PEF) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). PEF reflects airway patency and respiratory muscle strength.
Measured: FVC will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
Investigators plan to measure the changes of maximum expiratory flow rate at 25% vital capacity. MEF25% reflects the early stage of expiratory flow rate.
Measured: MEF25 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity using a portable spirometer (Jaeger Master screen V5.01; CareFusion). MEF50 reflects the interim stage of expiratory flow rate.
Measured: MEF50 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity (MEF75%) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). MEF75 reflects the terminal stage of expiratory flow rate.
Measured: MEF75 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after exposure)
Secondary outcomes (3)
Changes of fractional exhaled nitric oxide (FeNO)
Investigators plan to measure the changes of fractional exhaled nitric oxide using FeNO monitor (NIOX; Aerocrine AB, Solna, Sweden). FeNO reflects airway inflammation level
Measured: FeNO will be examined half an hour before exposure and half an hour after exposure
Changes of fractional concentration of carbon monoxide (FeCO)
Investigators plan to measure the changes of fractional concentration of carbon monoxide using Pico Smokerlyzer. FeCO reflects level of carboxyhemoglobin in blood.
Measured: FeCO will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Changes of skin temperature
The changes of wrist skin temperature will be measured
Measured: Wrist skin temperature will be measured at 1:00 P.M. to 3:00 P.M. on the day of the exposure session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start16 Oct 2024
- Primary completion16 Nov 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung FunctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renjie Chen, Fudan University
- Investigators
- Haidong Kan, PhD, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652932
- Sponsor's protocol ID
- IRB#2024-10-1166
- Status last verified
- Feb 2025
- First submitted
- 15 Oct 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Low Temperature Exposure on Respiratory Health in Healthy Young Adults: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06652932
- Acronym / sponsor ID
- IRB#2024-10-1166
- Conditions
- Lung Function
- Keywords
- Low temperature, Randomized controlled trial, Lung function
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Oct 2024 (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.
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on respiratory health and the underlying mechanisms.
Detailed description
The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (15℃) and once to the moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include lung function tests and exhaled breath test. Investigators plan to collect blood, pharyngeal secretion, exhaled breath condensate and urine samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low temperature (15℃) group | Experimental | Other: Low temperature (15°C) groupSubjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber. |
| Moderate temperature (22℃) group | Experimental | Other: Moderate temperature (22°C) groupSubjects in the exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Living in Shanghai during the study period;
- Body mass index > 18.5 and ≤ 28;
- right-handed;
- receiving or having received higher education;
- with the ability to read and understand Chinese smoothly.
Key exclusion criteria (10 listed)
- Smoking and alcohol abuse;
- Current drug and dietary supplements intake;
- Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
- Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
- Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
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 |
|---|---|---|
| Low temperature (15°C) groupThe exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods. | Other | Low temperature (15℃) group |
| Moderate temperature (22°C) groupThe exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods. | Other | Moderate temperature (22℃) group |
Primary outcome
Changes of forced expiratory volume in the first second (FEV1)
Time frame: The tests will be conducted at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of the forced expiratory volume in 1 s (FEV1) using a smart spirometer (Model A1, BreathHome, China) supervised by professional medical staff. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion. FEV1 reflect pulmonary function.
Changes of forced vital capacity (FVC)
Time frame: FVC will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of forced vital capacity (FVC) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). FVC reflects the expiratory resistance of large airways.
Changes of peak expiratory flow rate (PEF)
Time frame: FVC will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of peak expiratory flow (PEF) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). PEF reflects airway patency and respiratory muscle strength.
Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
Time frame: MEF25 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of maximum expiratory flow rate at 25% vital capacity. MEF25% reflects the early stage of expiratory flow rate.
Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
Time frame: MEF50 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity using a portable spirometer (Jaeger Master screen V5.01; CareFusion). MEF50 reflects the interim stage of expiratory flow rate.
Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
Time frame: MEF75 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after exposure)
Investigators plan to measure the changes of maximum expiratory flow rate at 50% vital capacity (MEF75%) using a portable spirometer (Jaeger Master screen V5.01; CareFusion). MEF75 reflects the terminal stage of expiratory flow rate.
3 secondary outcomes
Changes of fractional exhaled nitric oxide (FeNO)
Time frame: FeNO will be examined half an hour before exposure and half an hour after exposure
Changes of fractional concentration of carbon monoxide (FeCO)
Time frame: FeCO will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
Changes of skin temperature
Time frame: Wrist skin temperature will be measured at 1:00 P.M. to 3:00 P.M. on the day of the exposure session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Haidong Kan, PhD study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low temperature (15°C) group and Moderate temperature (22°C) group in people with Lung Function, run by Fudan University at 1 site in China.
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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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 of forced expiratory volume in the first second (FEV1) (time frame: The tests will be conducted at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)). The study lists 6 primary outcomes in all. 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 27 Feb 2025.