Cardiopulmonary DiseasesNCT05172388
Indoor Air Filtration and Young Adults Health Study
A study testing Air purifier in people with Cardiopulmonary Diseases, run by Peking University at 1 site in China.
Trial summary
This study aims to explore the cardiopulmonary health effects of indoor air purification and other indoor environmental conditions among young healthy college students in Beijing, China. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Diseases
- What is being tested?
- Air purifier
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Living in Beijing for more than one consecutive years;
- College students between 18-28 years;
Who cannot join
- Current or past smokers;
- Body mass index (BMI) over 28.0 kg/m2.
- Alcohol addict;
- Having thoracic surgery history;
- History of diagnosed chronic disease;
- Hepatitis B / hepatitis C virus patient / carrier;
- Unwilling or unable to provide informed consent or cooperate with all research related procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiopulmonary Health Effects of Indoor Air Purification and Other Indoor Environmental Conditions Among Young Healthy Adults in Beijing, China
This study aims to explore the cardiopulmonary health effects of indoor air purification and other indoor environmental conditions among young healthy college students in Beijing, China.
Read the detailed description
The present randomized, double-blind crossover study was conducted to investigate the cardiopulmonary health effects of air purification among 81 young healthy college students in Beijing, China. Real or sham purification was performed in the dormitories for 4 days, following a 15-day wash-out period in the intervals. During the study periods, the investigators collected indoor exposure levels of size-fractionated particulate matter (PM), black carbon (BC), noise, ozone, nitrogen dioxide, carbon dioxide, volatile organic compounds, temperature, relative humidity, illumination, and microorganism. Biological specimens (i.e., morning urine, fasting venous blood, exhaled breath condensate, and nasal mucus) were also collected and examined. Some important individual factors including demographical information (age, sex, height, weight, etc.), physical activity, sleep condition, mood and cognition, and food intake were also gathered using questionaire or anthropometric measurements, in order to control for the potential confounding effects. For further data analyses, air pollutants, noise, and other exposures would be controlled as confounders when addressing the health effects associated with air purification, and would also be used to explore their effects on cardiopulmonary health. The interaction effects of air pollutants, noise, and other exposures on cardiopulmonary health would also be explored.
- Conditions
- Cardiopulmonary Diseases
- Being tested
- Air purifier
- Medical subject headings
- Pulmonary Heart Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air purifierOther
Real purification and sham purification would be conducted in the dormintory rooms (about 25 in total) of the study subjects for 4 days, following a randomized crossover design, which means a real air purifier and a sham purifier would be placed in the same dormintory room with a wash-out interval (15 days).
| Study group | Role | What they receive |
|---|---|---|
| Real purification | Active comparator | Air purifier turned on. Receives: Other: Air purifier |
| Sham purification | Sham comparator | Air purifier turned off. Receives: Other: Air purifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in heart rate variability
Including the standard deviation of all normal-to-normal R-R intervals (SDNN) in millisecond, standard deviation of sequential five-minute R-R interval means (SDANN) in millisecond, root-mean-square difference of successive normal R-R intervals (rMSSD) in millisecond, low frequency (LF) in squared millisecond, and high frequency (HF) in squared millisecond.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in blood pressure
Including the systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, and pulse pressure (PP) in mmHg.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in pulmonary function
Including forced expiratory volume in 1 s (FEV1) in liter, forced vital capacity (FVC) in liter, forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio, and peak expiratory flow (PEF) in liter per second.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Secondary outcomes (14)
Changes in levels of airway inflammation
Respiratory inflammation Fractional exhaled nitric oxide (FeNO) test would be conducted.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of C-reactive protein (CRP)
Examining the C-reactive protein (CRP) in blood sample to characterize the levels of inflammation.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of 8-hydroxydeoxyguanosine (8-OHdG)
Examining the 8-hydroxydeoxyguanosine (8-OHdG) in urine sample to characterize the levels of oxidative stress.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of sleep-related parameters
Including time in bed in minute, total sleep time and sleep stage time in minute. The time in bed and total sleep time would be calculated to sleep efficiency in percentage.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of sleep-breathing parameters
Including blood oxygen saturation in percentage and heart rate in bpm.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of cognitive function
Including short-term memory and delayed memory in unit measured by the standard Stroop Test, as well as executive function in unit measured by the Harmonized Cognitive Assessment Protocol.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of cognitive function-related biomarkers
Including serum brain derived nerve factor (BDNF) in ng/mL, S100B protein in ng/mL, and neuron-specific-enolase (NSE) in ng/mL.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of blood cell parameters
Including white blood cells in unit, red blood cells in unit, and platelets in unit measured by blood routine examination.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of systematic inflammation and oxidative stress indicators
Including interleukin-6 (IL-6) in unit, IL-8 in unit, IL-10 in unit, IL-13 in unit, IL-5 in unit, IL-1β in unit, IL-17A in unit, IL-12p70 in unit, tumor necrosis factor-α (TNF-α) in unit, interferon-γ (IFN-γ) in unit, monocyte chemoattratctant protein-1 (MCP-1) in unit, angiotensin II (Ang-II) in unit, superoxide dismutase (SOD) in unit, glutathione (GSH) in unit, nitric oxide levels (NOX) in unit.
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of glucose metabolites in serum
Serum samples were collected for targetted glucose metabolomics analysis using the gas chromatography and mass spectrometry (GC-MS).
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of neurotransmitter metabolites in serum
Serum samples were collected for targetted neurotransmitter metabolomics analysis using the gas chromatography and mass spectrometry (GC-MS).
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of microbiomics in nasal mucus
Nasal mucus samples were collected for microbiomics analysis to examine the microbial community abundance (α-diversity).
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of microbiomics in EBC
EBC samples were collected for microbiomics analysis to examine the microbial community abundance (α-diversity).
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of pituitary-related hormones
Including serum levels of cortisol, adreno-cortico-tropic-hormone (ACTH), and thyroid stimulating hormone (TSH).
Measured: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start29 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary DiseasesStudies of the same condition, open and under way.
- More trials run by Peking 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furong Deng, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172388
- Sponsor's protocol ID
- IRB00001052-21109
- Status last verified
- Oct 2022
- First submitted
- 30 Nov 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Health Effects of Indoor Air Purification and Other Indoor Environmental Conditions Among Young Healthy Adults in Beijing, China
- ClinicalTrials.gov ID
- NCT05172388
- Acronym / sponsor ID
- IRB00001052-21109
- Conditions
- Cardiopulmonary Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 Dec 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 the cardiopulmonary health effects of indoor air purification and other indoor environmental conditions among young healthy college students in Beijing, China.
Detailed description
The present randomized, double-blind crossover study was conducted to investigate the cardiopulmonary health effects of air purification among 81 young healthy college students in Beijing, China. Real or sham purification was performed in the dormitories for 4 days, following a 15-day wash-out period in the intervals. During the study periods, the investigators collected indoor exposure levels of size-fractionated particulate matter (PM), black carbon (BC), noise, ozone, nitrogen dioxide, carbon dioxide, volatile organic compounds, temperature, relative humidity, illumination, and microorganism. Biological specimens (i.e., morning urine, fasting venous blood, exhaled breath condensate, and nasal mucus) were also collected and examined. Some important individual factors including demographical information (age, sex, height, weight, etc.), physical activity, sleep condition, mood and cognition, and food intake were also gathered using questionaire or anthropometric measurements, in order to control for the potential confounding effects. For further data analyses, air pollutants, noise, and other exposures would be controlled as confounders when addressing the health effects associated with air purification, and would also be used to explore their effects on cardiopulmonary health. The interaction effects of air pollutants, noise, and other exposures on cardiopulmonary health would also be explored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real purification | Active comparator | Other: Air purifierAir purifier turned on. |
| Sham purification | Sham comparator | Other: Air purifierAir purifier turned off. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Living in Beijing for more than one consecutive years;
- College students between 18-28 years;
Key exclusion criteria (7 listed)
- Current or past smokers;
- Body mass index (BMI) over 28.0 kg/m2.
- Alcohol addict;
- Having thoracic surgery history;
- History of diagnosed chronic disease;
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 purifierReal purification and sham purification would be conducted in the dormintory rooms (about 25 in total) of the study subjects for 4 days, following a randomized crossover design, which means a real air purifier and a sham purifier would be placed in the same dormintory room with a wash-out interval (15 days). | Other | Real purification, Sham purification |
Primary outcome
Changes in heart rate variability
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Including the standard deviation of all normal-to-normal R-R intervals (SDNN) in millisecond, standard deviation of sequential five-minute R-R interval means (SDANN) in millisecond, root-mean-square difference of successive normal R-R intervals (rMSSD) in millisecond, low frequency (LF) in squared millisecond, and high frequency (HF) in squared millisecond.
Changes in blood pressure
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Including the systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, and pulse pressure (PP) in mmHg.
Changes in pulmonary function
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Including forced expiratory volume in 1 s (FEV1) in liter, forced vital capacity (FVC) in liter, forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio, and peak expiratory flow (PEF) in liter per second.
14 secondary outcomes
Changes in levels of airway inflammation
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of C-reactive protein (CRP)
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of 8-hydroxydeoxyguanosine (8-OHdG)
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of sleep-related parameters
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of sleep-breathing parameters
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of cognitive function
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of cognitive function-related biomarkers
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of blood cell parameters
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of systematic inflammation and oxidative stress indicators
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of glucose metabolites in serum
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of neurotransmitter metabolites in serum
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of microbiomics in nasal mucus
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of microbiomics in EBC
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Changes in levels of pituitary-related hormones
Time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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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 in people with Cardiopulmonary Diseases, run by Peking 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 13 Oct 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 in heart rate variability (time frame: Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)). The study lists 3 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 13 Oct 2022.