Indoor Air and Children Health Study

Cardiopulmonary Health Effects of Indoor Air Purification and Different Indoor Environmental Factors Among School Children in Beijing

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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Disease
• Intervention / Treatment: Other: Air purifier

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • School of Pubic Health, Peking University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Real purification; Air purifier turned on	Other: Air purifier; active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design
Sham Comparator: Sham purification; Air purifier turned off	Other: Air purifier; active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking University
• Investigators: Principal Investigator: Furong Deng, PhD&MD, Peking University

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 21, 2017
• First Posted (Actual): October 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pulmonary Heart Disease
• Other Study ID Numbers: FDeng17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No