Acute Effects of Low Temperature Exposure on Respiratory System

NCT ID: NCT06652932

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-16
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Low temperature (15℃) group

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

Group Type: EXPERIMENTAL

Low temperature (15°C) group

Intervention Type: OTHER

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℃) group

Subjects in the exposure group will be exposed to moderate temperature (22℃) for about 2 hours in a chamber.

Group Type: EXPERIMENTAL

Moderate temperature (22°C) group

Intervention Type: OTHER

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

Interventions

Low temperature (15°C) group

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

Intervention Type: OTHER

Moderate temperature (22°C) group

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Renjie Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haidong Kan, PhD

Role: STUDY_DIRECTOR

Fudan University

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IRB#2024-10-1166

Identifier Type: -

Identifier Source: org_study_id