Acute Health Effects of Low Temperature Exposure

Fudan University

Status: Not yet enrolling

Conditions: Cognitive Function; Cardiovascular System; Respiratory System

Treatments: Other: Moderate temperature (22#) group; Other: Low temperature (16#) group

Study type: Interventional

Funder types: Other

Identifiers

NCT06076629

FDUEH-9

Details and patient eligibility

About

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low temperature exposure and the underlying mechanisms.

Full description

The investigators will conduct a randomized controlled human exposure crossover study among about 50 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (16#) and once to the moderate temperature (22#) in a chamber for about 2-2.5 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure (within 1 hour before the exposure session), during the period of exposure, and after exposure (within 2 hours after the exposure session). Health examinations include spirometry, Holter monitoring, blood pressure tests, cognitive function tests, symptom questionnaires, and magnetic resonance imaging. Investigators plan to collect blood, urine, exhaled breath condensate, and oropharyngeal swabs samples.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Low temperature (16#) group

Experimental group

Description:

Subjects in exposure group will be exposed to low temperature (16#) for about 2 hours in a chamber.

Treatment:

Other: Low temperature (16#) group

Moderate temperature (22#) group

Sham Comparator group

Description:

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

Treatment:

Other: Moderate temperature (22#) group