Health Benefits of Air Purifiers in Primary School Students

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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).

Study 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.

Eligibility

Primary outcome measure(s)

• Changes of heart rate variability — Baseline and after the completion of intervention period (4 months anticipated)
  Nihon Kohden Electrocardiograph and Carepatch Electrocardiogram are used to measure heart rate variability, including standard deviation of all normal-to-normal R-R intervals (SDNN), standard deviation of sequential five-minute R-R interval means (SDANN), root-mean-square difference of successive normal R-R intervals (RMSSD), low frequency (LF), and high frequency (HF) in intervention and control groups. To eliminate possible errors, measurements are conducted by the same trained staff using the same instrument.
• Changes of forced expiratory volume in 1 s (FEV1) — Baseline and after the completion of intervention period (4 months anticipated)
  The pulmonary function measures are performed by the professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject in a sitting position and clamp the nose clip, and repeat the test, with the best result as the criterion.
• Changes of forced vital capacity (FVC) — Baseline and after the completion of intervention period (4 months anticipated)
  The pulmonary function measures are performed by the professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject in a sitting position and clamp the nose clip, and repeat the test, with the best result as the criterion.
• Changes of forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio — Baseline and after the completion of intervention period (4 months anticipated)
  The pulmonary function measures are performed by the professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject in a sitting position and clamp the nose clip, and repeat the test, with the best result as the criterion.
• Changes of peak expiratory flow (PEF) — Baseline and after the completion of intervention period (4 months anticipated)
  The pulmonary function measures are performed by the professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject in a sitting position and clamp the nose clip, and repeat the test, with the best result as the criterion.
• Changes of fractional exhaled nitric oxide (FeNO) levels — Baseline and after the completion of intervention period (4 months anticipated)
  A NIOX VERO Sensor is used to measure fractional exhaled nitric oxide (FeNO) as a biomarker for airway inflammation. After deep breathing, the subjects gently inhaled into the device. The instrument shows FeNO level of the subjects.
• Changes of fractional exhaled carbon monoxide (FeCO) levels — Baseline and after the completion of intervention period (4 months anticipated)
  Use PICO to measure fractional exhaled carbon monoxide (FeCO) as a biomarker for cardiovascular risk. After deep breathing and holding the breath for 15 seconds, the subjects gently inhaled into the device. The instrument shows FeCO level of the subjects.
• Changes of blood pressure — Baseline and after the completion of intervention period (4 months anticipated)
  Using Omron blood pressure monitor to measure the systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure for each subject by the trained staff using the same instrument.

Trial sites (1)

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