Health Benefits of Air Purifiers in Primary School Students

NCT05016271 | Active Not Recruiting DMC

• 1 other identifier: FDUEH-7
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiopulmonary Function; Child

Keywords

Air pollution; Particulate matter; Air Purifiers; Cardiopulmonary system

Outcome Measures

Primary Outcomes (8)

• Changes of heart rate variability

  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.

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of forced expiratory volume in 1 s (FEV1)

  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.

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of forced vital capacity (FVC)

  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.

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio

  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.

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of peak expiratory flow (PEF)

  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.

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of fractional exhaled nitric oxide (FeNO) levels

  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.

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of fractional exhaled carbon monoxide (FeCO) levels

  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.

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of blood pressure

  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.

  Baseline and after the completion of intervention period (4 months anticipated)

Secondary Outcomes (4)

• Changes of C-reactive protein (CRP)

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of 8-hydroxydeoxyguanosine (8-OHdG)

  Baseline and after the completion of intervention period (4 months anticipated)

• Changes of persistent response (PR)

  Baseline and after the completion of intervention period (4 months anticipated)

• Differences in metabolite levels detected in metabolomics between groups of intervention and control.

  Baseline and after the completion of intervention period (4 months anticipated)

Study Arms (2)

True air purifier group

EXPERIMENTAL

Children in this group will receive an intervention of air purifiers with high-efficiency particulate air (HEPA) filters.

Behavioral: Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters

Sham air purifier group

SHAM COMPARATOR

Children in this group will receive an intervention of air purifiers without high-efficiency particulate air (HEPA) filters.

Behavioral: Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters

Interventions

Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters BEHAVIORAL

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).

True air purifier group

Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters BEHAVIORAL

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).

Sham air purifier group

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age of between 8 and 12 years old
• Males and female of ethnic Han
• Subjects who have no plans to change classroom during the intervention period
• Subjects who staying in Jiaozuo city during the intervention period

You may not qualify if:

• Subjects with asthma, childhood diabetes, childhood hypertension, and behavioral disorders
• Subjects who plan to transfer or move offsite within six months
• Subjects who decorated or plan to decorate home within six months
• Subjects with smokers in the household

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Air Filters

Intervention Hierarchy (Ancestors)

Filtration; Chemistry Techniques, Analytical; Investigative Techniques; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 23, 2021
• Study Start: September 22, 2021
• Primary Completion: June 30, 2022
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CN (1)