Indoor Air and Children Health Study

Not Applicable

Completed

• Conditions: Cardiopulmonary Disease
• Interventions: Other: Air purifier

• Registration Number: NCT03319056
• Lead Sponsor: Peking University

Brief Summary

The objective of this study is to investigate the cardiopulmonary health effects of indoor air purification and different indoor environmental factors among school students in Beijing.

Detailed Description

This randomized, double-blind crossover study was conducted to explore the cardiopulmonary effects of ionization air purification among 48 children in Beijing. Real or sham purification was performed in classrooms for 5 weekdays in a random order with a 2-month wash-out period. During the study periods, different indoor environmental factors were monitored including size-fractionated particulate matter (PM), black carbon (BC), ozone, carbon dioxide (CO2), negative air ions (NAI), noise, temperature and relative humidity, which were controlled as confounders in the analysis of the effects of indoor air purification. In addition, we analyzed the cardiopulmonary effects of those environmental factors on the children.

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-21
• Study First Posted: 2017-10-24
• Study Start: 2017-12-11
• Primary Completion: 2018-04-01
• Study Completion: 2018-04-01
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-21
• Last Update Posted: 2019-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• living in Beijing for more than two consecutive years;
• living in school dormitories from Monday to Friday.

Exclusion Criteria

• suffering any health condition;
• having asthma or thoracic surgery history.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham purification	Air purifier	Air purifier turned off
Real purification	Air purifier	Air purifier turned on

Primary Outcome Measures

Name	Time	Method
Levels of lung function indicators	10 weekdays for intervention (active or sham) and 2 wash-out months	Lung function test was conducted including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).

Secondary Outcome Measures

Name	Time	Method
Levels of urinary metabolomics	10 weekdays for intervention (active or sham) and 2 wash-out months	Urine samples were collected for metabolomics analysis.
Changes in ST-segment elevation	10 weekdays for intervention (active or sham) and 2 wash-out months	Ambulatory electrocardiogram (ECG) was monitored.
Levels of oxidative stress in Exhaled Breath Condensate (EBC)	10 weekdays for intervention (active or sham) and 2 wash-out months	EBC was collected using a designated device for oxidative stress analysis.
Changes in autonomic cardiac function	10 weekdays for intervention (active or sham) and 2 wash-out months	Ambulatory electrocardiogram (ECG) was monitored including heart rate (HR) and heart rate variability (HRV).
Level of respiratory inflammation	10 weekdays for intervention (active or sham) and 2 wash-out months	Fractional exhaled nitric oxide (FeNO) test was conducted.

Trial Locations

Locations (1)

School of Pubic Health, Peking University; 🇨🇳 Beijing, Beijing, China