The Health Benefits of Indoor Air Filtration Among Children

Sponsor
Tiantian Li (Other)
Overall Status
Recruiting
CT.gov ID
NCT04835337
Collaborator
(none)
110
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2
12.2
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Study Details

Study Description

Brief Summary

This study aims to explore the health benefits of air purifier on the impact of air pollutants on children's health.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Air Purifiers
  • Behavioral: Sham Air Purifiers
N/A

Detailed Description

From April 2021 to November 2021, researchers conduct a randomized double-blind crossover trial on 110 healthy children in Jiaozuo City, Henan Province. The children are divided into two groups according to their classes and alternated the use of true or sham purifiers devices, including air purifiers and fresh air system. Air purifiers are installed in the classroom and bedrooms of the children. Fresh air system are installed in the classroom. A total of 6 epidemiological surveys are conducted on the subjects, with an interval of 60 days or more. All participants and research staffs were blinded to the group assignment. In addition, air pollutant exposure monitoring, questionnaire surveys, physical examinations, and biological sample collection are conducted on the research subjects each time. The biological samples are further tested for the concentration levels of related biomarkers such as the respiratory system, cardiovascular system, metabolic system, and nervous system. Furthermore, comprehensive evaluation of children's behavioral ability is also carried out.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Investigating the Health Benefits of Indoor Air Filtration Among Children: a Randomized Crossover Trial in Jiaozuo, China
Actual Study Start Date :
Apr 10, 2021
Anticipated Primary Completion Date :
Nov 15, 2021
Anticipated Study Completion Date :
Apr 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Air purifier

Participants in this group receive an intervention of real air purifiers placed in the indoor environment.

Behavioral: Air Purifiers
Students are divided into two groups: intervention group and control group. The intervention team places an air purifier in the indoor environment to intervene. All the indoor environment of the group use the same qualified air purifier, and all participants and research staffs are blinded to the group assignment.

Sham Comparator: Control

Participants in this group receive an intervention of sham air purifiers, we just remove the filter in the purifiers, and the other treatments are the same as the real purification group.

Behavioral: Sham Air Purifiers
The control group is also intervened. The intervention is to place a sham air purifier (remove the filter screen) in the indoor environment, and all the indoor environment use the same air purifier as the intervention group. All participants and research staffs are blinded to the group assignment.

Outcome Measures

Primary Outcome Measures

  1. Changes of Forced Vital Capacity of Lung Function [Baseline and at the end of each 60 days intervention period]

    The pulmonary function measures are performed by the professional medical staff. Before the pulmonary function test, subjects practice several times by themselves. During the examination, each subject stand and clamp the nose clip, and repeat the test, with the best result as the criterion.

  2. Changes of FeNO [Baseline and at the end of each 60 days intervention period]

    Use NIOX VERO Sensor to measure fractional exhaled nitric oxide (FeNO) as a biomarker for formaldehyde inhalation exposure. After deep breathing, the subjects gently inhaled into the device. The instrument showed FeNO level of the subjects.

  3. Changes of FeCO [Baseline and at the end of each 60 days intervention period]

    Use Pico Smokerlyzer to measure fractional exhaled carbon monoxide (FeCO). After deep breathing, the subjects held their breath for 15 seconds and then gently inhaled into the device. The instrument showed FeCO level and the estimated value of carboxyhemoglobin in blood.

  4. Changes of Systolic Blood Pressure [Baseline and at the end of each 60 days intervention period]

    Systolic blood pressure for each subject is conducted by the same trained staff using the same instrument. Average levels are calculated by the treatments of intervention or control.

  5. Changes of LF/HF of HRV [Baseline and at the end of each 60 days intervention period]

    Use Nihon Kohden Electrocardiograph to measure heart rate variability and examine the ratio between low frequency and high frequency (LF/HF). To eliminate possible error, subjects are conducted by the same trained staff using the same instrument.

Secondary Outcome Measures

  1. Changes of CRP [Baseline and at the end of each 60 days intervention period]

    Detect the concentration of C-reactive protein in blood sample to examine the different level of inflammation between the group of intervention and control.

  2. Changes of 8-OHdG [Baseline and at the end of each 60 days intervention period]

    Detect the concentration of 8-hydroxydeoxyguanosine (8-OHdG) in urine sample as a marker of generalized, cellular oxidative stress to DNA.

  3. Changes of PR [Baseline and at the end of each 60 days intervention period]

    Examine persistent response (PR) as the index to test the focus ability of children. The test is performed by the Wsiconsin card sorting test through computer, and the index reflects the ability of cognitive transfer. The normal value is less than or equal to 27.

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 8 ≤ 12 years old

  • Volunteer to participate in this study

Exclusion Criteria:
  • Current and past medical history, including asthma, childhood diabetes, childhood hypertension, behavior-related diseases

  • Students who plan to transfer or move within six months

  • Unable to cooperate with follow-up

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of Environmental Health, Chinese Center for Disease Control and Prevention Beijing China 100021

Sponsors and Collaborators

  • Tiantian Li

Investigators

  • Study Director: Tiantian Li, National Institute of Environmental Health, Chinese Center for Disease Control and Prevention

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tiantian Li, professor, Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier:
NCT04835337
Other Study ID Numbers:
  • 202032
First Posted:
Apr 8, 2021
Last Update Posted:
Jul 28, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 28, 2021