Health Benefits of Air Purifiers in Primary School Students

NCT ID: NCT05016271

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-22
• Study Completion Date: 2026-06-30

Brief Summary

This study aims to explore changes in cardiopulmonary function and other health indicators in primary school students with the intervention of air purifiers on a randomized controlled trial.

Detailed Description

The investigators will conduct a randomized controlled trial among 110 healthy children in Jiaozuo city, Henan, China. The eligible children will be divided into two groups according to their classes and randomly receive interventions of either true or sham air purifiers. The air purifiers devices in classroom [air purifiers and fresh air ventilation systems] will operate during the school time and the devices in bedrooms (air purifiers) operate during the home time in the intervention period. All the participants and investigators will be blinded to the group assignment. Epidemiological questionnaires (i.e., basic characteristics, eating habits, daily schedule, etc.) will be conducted and health indicators (i.e., blood pressure, pulmonary function indicators, fractional exhaled nitric oxide, and fractional exhaled carbon monoxide) and biological specimens (i.e., morning urine, venous blood, exhaled breath condensate, and feces) will be evaluated and collected at baseline and after the completion of intervention period (4 months anticipated).

Conditions

Cardiopulmonary Function; Child

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

True air purifier group

Children in this group will receive an intervention of air purifiers with high-efficiency particulate air (HEPA) filters.

Group Type: EXPERIMENTAL

Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters

Intervention Type: BEHAVIORAL

This group will receive an intervention of true air purifiers. The air purifiers in classroom (air purifiers and fresh air ventilation systems with HEPA filters) will operate during the school time and the air purifiers in bedrooms (air purifiers with HEPA filters) operate during the home time in the intervention period (4 months anticipated).

Sham air purifier group

Children in this group will receive an intervention of air purifiers without high-efficiency particulate air (HEPA) filters.

Group Type: SHAM_COMPARATOR

Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters

Intervention Type: BEHAVIORAL

This group will receive an intervention of sham air purifiers. The air purifiers in classroom (air purifiers and fresh air ventilation systems without HEPA filters) will operate during the school time and the air purifiers in bedrooms (air purifiers without HEPA filters) operate during the home time in the intervention period (4 months anticipated).

Interventions

Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters

This group will receive an intervention of true air purifiers. The air purifiers in classroom (air purifiers and fresh air ventilation systems with HEPA filters) will operate during the school time and the air purifiers in bedrooms (air purifiers with HEPA filters) operate during the home time in the intervention period (4 months anticipated).

Intervention Type: BEHAVIORAL

Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters

This group will receive an intervention of sham air purifiers. The air purifiers in classroom (air purifiers and fresh air ventilation systems without HEPA filters) will operate during the school time and the air purifiers in bedrooms (air purifiers without HEPA filters) operate during the home time in the intervention period (4 months anticipated).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age of between 8 and 12 years old
• Males and female of ethnic Han
• Subjects who have no plans to change classroom during the intervention period
• Subjects who staying in Jiaozuo city during the intervention period

Exclusion Criteria

• Subjects with asthma, childhood diabetes, childhood hypertension, and behavioral disorders
• Subjects who plan to transfer or move offsite within six months
• Subjects who decorated or plan to decorate home within six months
• Subjects with smokers in the household

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Haidong Kan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FDUEH-7

Identifier Type: -

Identifier Source: org_study_id