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Indoor Air and Children Health Study

Sponsor
Peking University (Other)
Overall Status
Completed
CT.gov ID
NCT03319056
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
3.6
Actual Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Air purifier
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Cardiopulmonary Health Effects of Indoor Air Purification and Different Indoor Environmental Factors Among School Children in Beijing
Actual Study Start Date :
Dec 11, 2017
Actual Primary Completion Date :
Apr 1, 2018
Actual Study Completion Date :
Apr 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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).

  2. Level of respiratory inflammation [10 weekdays for intervention (active or sham) and 2 wash-out months]

    Fractional exhaled nitric oxide (FeNO) test was conducted.

  3. Changes in ST-segment elevation [10 weekdays for intervention (active or sham) and 2 wash-out months]

    Ambulatory electrocardiogram (ECG) was monitored.

  4. 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.

  5. Levels of urinary metabolomics [10 weekdays for intervention (active or sham) and 2 wash-out months]

    Urine samples were collected for metabolomics analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Pubic Health, Peking University Beijing Beijing China 100191

Sponsors and Collaborators

  • Peking University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Furong Deng, MD & PhD, Professor, Deputy Director of Department of Occupational & Environmental Health Sciences, Peking University
ClinicalTrials.gov Identifier:
NCT03319056
Other Study ID Numbers:
  • FDeng17
First Posted:
Oct 24, 2017
Last Update Posted:
May 23, 2019
Last Verified:
May 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pulmonary Heart Disease

Study Results

No Results Posted as of May 23, 2019