Acute Health Effects of High Temperature Exposure

NCT ID: NCT05575752

Last Updated: 2025-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-23

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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The investigators will conduct a randomized controlled human exposure crossover study among about 30 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the high temperature (32℃) and once to 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 symptom questionnaire, blood pressure tests, cognitive function tests, magnetic resonance imaging, skin tests, spirometry, and Holter monitoring. Investigators plan to collect blood, urine and oropharyngeal swabs samples.

Conditions

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Cardiovascular System Respiratory System Cognitive Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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high temperature (32℃) group

Subjects in exposure group will be exposed to high temperature (32℃) for about 2 hours in a chamber.

Group Type EXPERIMENTAL

high temperature (32℃) group

Intervention Type OTHER

The exposure group will be exposed to high temperature (32℃) in a chamber for about 2 hours, resting during the whole periods.

moderate temperature (22℃) group

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

Group Type SHAM_COMPARATOR

moderate temperature (22℃) group

Intervention Type OTHER

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

Interventions

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high temperature (32℃) group

The exposure group will be exposed to high temperature (32℃) in a chamber for about 2 hours, resting during the whole periods.

Intervention Type OTHER

moderate temperature (22℃) group

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

Intervention Type OTHER

Eligibility Criteria

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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 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

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Haidong Kan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haidong Kan, PhD

Role: STUDY_DIRECTOR

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

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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FDUEH-8

Identifier Type: -

Identifier Source: org_study_id

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