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Completed

NCT Number: NCT03319056

Indoor Air and Children Health Study

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.

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Key information

Conditions

Cardiopulmonary Disease Cardiovascular Diseases Heart Diseases Pulmonary Heart Disease

Age range

10 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Pubic Health, Peking University

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Air purifier

Other

active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design

Primary outcomes

  1. Levels of lung function indicators

    Time frame: 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 outcomes

  1. Changes in autonomic cardiac function

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 10 weekdays for intervention (active or sham) and 2 wash-out months

    Urine samples were collected for metabolomics analysis.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2017
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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