Cardiopulmonary FunctionNCT05016271
Health Benefits of Air Purifiers in Primary School Students
A study testing Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters and Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters in people with Cardiopulmonary Function and Child, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Function, Child
- What is being tested?
- Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters and Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Health Benefits of Air Purifiers in Primary School Students: A Randomized Controlled Trial
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.
Read the detailed description
The investigators will conduct a randomized controlled trial among 110 healthy children in Jiaozuo city, Henan, China. The eligible children will be divided into two groups according to their classes and randomly receive interventions of either true or sham air purifiers. The air purifiers devices in classroom [air purifiers and fresh air ventilation systems] will operate during the school time and the devices in bedrooms (air purifiers) operate during the home time in the intervention period. All the participants and investigators will be blinded to the group assignment. Epidemiological questionnaires (i.e., basic characteristics, eating habits, daily schedule, etc.) will be conducted and health indicators (i.e., blood pressure, pulmonary function indicators, fractional exhaled nitric oxide, and fractional exhaled carbon monoxide) and biological specimens (i.e., morning urine, venous blood, exhaled breath condensate, and feces) will be evaluated and collected at baseline and after the completion of intervention period (4 months anticipated).
- Conditions
- Cardiopulmonary Function, Child
- Being tested
- Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters, Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters
- Keywords
- Air pollution, Particulate matter, Air Purifiers, Cardiopulmonary system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filtersBehavioural
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) filtersBehavioural
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 group | Role | What they receive |
|---|---|---|
| True air purifier group | Experimental | Children in this group will receive an intervention of air purifiers with high-efficiency particulate air (HEPA) filters. Receives: 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. Receives: Behavioral: Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and after the completion of intervention period (4 months anticipated)
Secondary outcomes (4)
Changes of C-reactive protein (CRP)
Detect the concentration of C-reactive protein (CRP) in blood sample to examine the different level of inflammation between the groups of intervention and control.
Measured: Baseline and after the completion of intervention period (4 months anticipated)
Changes of 8-hydroxydeoxyguanosine (8-OHdG)
Detect the concentration of 8-hydroxydeoxyguanosine (8-OHdG) in urine sample of groups of intervention and control. 8-OHdG is a biomarker for DNA oxidative damage.
Measured: Baseline and after the completion of intervention period (4 months anticipated)
Changes of persistent response (PR)
Examine persistent response (PR) as the index to test the focus ability of children. The test is performed by the Wisconsin Card Sorting Test (WCST) through a computer, and the index reflects the ability of cognitive transfer. The normal value is less than or equal to 27.
Measured: Baseline and after the completion of intervention period (4 months anticipated)
Differences in metabolite levels detected in metabolomics between groups of intervention and control.
Mass spectrometry-based serum metabolomics is non-targeted. The study is to explore the differential metabolites in blood/urine/exhaled breath condensate (EBC) samples of the groups of intervention and control.
Measured: Baseline and after the completion of intervention period (4 months anticipated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start22 Sep 2021
- Primary completion30 Jun 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary FunctionStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidong Kan, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016271
- Sponsor's protocol ID
- FDUEH-7
- Status last verified
- Feb 2026
- First submitted
- 11 Aug 2021
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Benefits of Air Purifiers in Primary School Students: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05016271
- Acronym / sponsor ID
- FDUEH-7
- Conditions
- Cardiopulmonary Function, Child
- Keywords
- Air pollution, Particulate matter, Air Purifiers, Cardiopulmonary system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators will conduct a randomized controlled trial among 110 healthy children in Jiaozuo city, Henan, China. The eligible children will be divided into two groups according to their classes and randomly receive interventions of either true or sham air purifiers. The air purifiers devices in classroom [air purifiers and fresh air ventilation systems] will operate during the school time and the devices in bedrooms (air purifiers) operate during the home time in the intervention period. All the participants and investigators will be blinded to the group assignment. Epidemiological questionnaires (i.e., basic characteristics, eating habits, daily schedule, etc.) will be conducted and health indicators (i.e., blood pressure, pulmonary function indicators, fractional exhaled nitric oxide, and fractional exhaled carbon monoxide) and biological specimens (i.e., morning urine, venous blood, exhaled breath condensate, and feces) will be evaluated and collected at baseline and after the completion of intervention period (4 months anticipated).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| True air purifier group | Experimental | Behavioral: Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filtersChildren in this group will receive an intervention of air purifiers with high-efficiency particulate air (HEPA) filters. |
| Sham air purifier group | Sham comparator | Behavioral: Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filtersChildren in this group will receive an intervention of air purifiers without high-efficiency particulate air (HEPA) filters. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filtersThis 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). | Behavioural | True air purifier group |
| Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filtersThis 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). | Behavioural | Sham air purifier group |
Primary outcome
Changes of heart rate variability
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Changes of C-reactive protein (CRP)
Time frame: Baseline and after the completion of intervention period (4 months anticipated)
Changes of 8-hydroxydeoxyguanosine (8-OHdG)
Time frame: Baseline and after the completion of intervention period (4 months anticipated)
Changes of persistent response (PR)
Time frame: Baseline and after the completion of intervention period (4 months anticipated)
Differences in metabolite levels detected in metabolomics between groups of intervention and control.
Time frame: Baseline and after the completion of intervention period (4 months anticipated)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters and Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters in people with Cardiopulmonary Function and Child, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of heart rate variability (time frame: Baseline and after the completion of intervention period (4 months anticipated)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.