- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04835337
The Health Benefits of Indoor Air Filtration Among Children
February 5, 2024 updated by: Tiantian Li
Investigating the Health Benefits of Indoor Air Filtration Among Children: a Randomized Crossover Trial in Jiaozuo, China
This study aims to explore the health benefits of air purifier on the impact of air pollutants on children's health.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100021
- National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Air purifier
Participants in this group receive an intervention of real air purifiers placed in the indoor environment.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Forced Vital Capacity of Lung Function
Time Frame: 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.
|
Baseline and at the end of each 60 days intervention period
|
Changes of FeNO
Time Frame: 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.
|
Baseline and at the end of each 60 days intervention period
|
Changes of FeCO
Time Frame: 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.
|
Baseline and at the end of each 60 days intervention period
|
Changes of Systolic Blood Pressure
Time Frame: 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.
|
Baseline and at the end of each 60 days intervention period
|
Changes of LF/HF of HRV
Time Frame: 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.
|
Baseline and at the end of each 60 days intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of CRP
Time Frame: 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.
|
Baseline and at the end of each 60 days intervention period
|
Changes of 8-OHdG
Time Frame: 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.
|
Baseline and at the end of each 60 days intervention period
|
Changes of PR
Time Frame: 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.
|
Baseline and at the end of each 60 days intervention period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tiantian Li, National Institute of Environmental Health, Chinese Center for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2021
Primary Completion (Actual)
November 15, 2021
Study Completion (Actual)
April 15, 2022
Study Registration Dates
First Submitted
March 30, 2021
First Submitted That Met QC Criteria
April 6, 2021
First Posted (Actual)
April 8, 2021
Study Record Updates
Last Update Posted (Estimated)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 202032
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Protective Effect of Air Purifier on Children's Health
-
Assiut UniversityNot yet recruitingIron Study of Neonates: Factors Affecting and Impact on Their Health Status at Birth in Assuit University Children's Hospital
-
Winthrop University HospitalNational Institute on Aging (NIA)CompletedDetermine Effect of Vitamin D on Bone Health in Elderly African American WomenUnited States
-
Harvard Pilgrim Health CareEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedEffect of Breastfeeding on Maternal and Child Health OutcomesBelarus
Clinical Trials on Air Purifiers
-
Norwegian Institute of Public HealthSINTEF Health ResearchActive, not recruitingFeasibility | AcceptabilityNorway
-
Fudan UniversityCompletedInflammation | Blood Pressure | Pulmonary Function | CoagulationChina
-
Fudan UniversityCompleted
-
University of MichiganNational Institute of Nursing Research (NINR); Michigan State UniversityRecruitingCardiometabolic HealthUnited States
-
AlyatecCompletedAsthma | AllergyFrance
-
Assistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseTerminated
-
University of MichiganJRD Enterprises LLC; Michigan Corporate Relations Network Small Company Innovation...CompletedStroke | Spinal Cord Injuries | Healthy AdultsUnited States
-
Fudan UniversityRecruiting
-
Beth Israel Deaconess Medical CenterNational Institute of Environmental Health Sciences (NIEHS)Enrolling by invitation
-
University of MichiganNational Institute of Environmental Health Sciences (NIEHS)Completed