Acute Effects of Low Temperature Exposure on Respiratory System

NCT06652932 | Active Not Recruiting DMC

• 1 other identifier: IRB#2024-10-1166
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Function

Keywords

Low temperature; Randomized controlled trial; Lung function

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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)

  FeNO will be examined half an hour before exposure and half an hour after exposure

• Changes of fractional concentration of carbon monoxide (FeCO)

  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

  Wrist skin temperature will be measured at 1:00 P.M. to 3:00 P.M. on the day of the exposure session

Other Outcomes (5)

• Differences in protein levels detected in blood Clara cell protein (CC16) between the two exposures

  CC16 will be examined at 1:00 P.M. and 4:00 P.M. (one hour after the exposure) on the day of the exposure session

• Differences in protein levels detected in blood chitinase-3-like protein 1 (YKL-40) between the two exposures

  YKL-40 will be examined at 1:00 P.M. and 4:00 P.M. (one hour after exposure) on the day of the exposure session

• Differences in protein levels detected in blood Surfactant Protein-D (SP-D) between the two exposures

  SP-D will be examined at 1:00 P.M. and 4:00 P.M. (one hour after exposure) on the day of the exposure session

Study Arms (2)

Low temperature (15℃) group

EXPERIMENTAL

Subjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber.

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.

Other: Moderate temperature (22°C) group

Interventions

Low temperature (15°C) group OTHER

The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods.

Low temperature (15℃) group

Moderate temperature (22°C) group OTHER

The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.

Moderate temperature (22℃) group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Cold Temperature; Population Groups

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health; Demography; Population Characteristics

Study Officials

• Haidong Kan, PhD

  Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 22, 2024
• Study Start: October 16, 2024
• Primary Completion: November 16, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)