- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05172388
Indoor Air Filtration and Young Adults Health Study
October 10, 2022 updated by: Furong Deng, Peking University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
81
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
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Beijing, China, 100191
- Peking University
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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
18 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Living in Beijing for more than one consecutive years;
- College students between 18-28 years;
Exclusion Criteria:
- 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.
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 |
---|---|
Active Comparator: Real purification
Air purifier turned on.
|
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).
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Sham Comparator: Sham purification
Air purifier turned off.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Including the systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, and pulse pressure (PP) in mmHg.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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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.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Respiratory inflammation Fractional exhaled nitric oxide (FeNO) test would be conducted.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Examining the C-reactive protein (CRP) in blood sample to characterize the levels of inflammation.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Examining the 8-hydroxydeoxyguanosine (8-OHdG) in urine sample to characterize the levels of oxidative stress.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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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.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Including blood oxygen saturation in percentage and heart rate in bpm.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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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.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Including serum brain derived nerve factor (BDNF) in ng/mL, S100B protein in ng/mL, and neuron-specific-enolase (NSE) in ng/mL.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Including white blood cells in unit, red blood cells in unit, and platelets in unit measured by blood routine examination.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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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.
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Serum samples were collected for targetted glucose metabolomics analysis using the gas chromatography and mass spectrometry (GC-MS).
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Serum samples were collected for targetted neurotransmitter metabolomics analysis using the gas chromatography and mass spectrometry (GC-MS).
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Nasal mucus samples were collected for microbiomics analysis to examine the microbial community abundance (α-diversity).
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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EBC samples were collected for microbiomics analysis to examine the microbial community abundance (α-diversity).
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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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)
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Including serum levels of cortisol, adreno-cortico-tropic-hormone (ACTH), and thyroid stimulating hormone (TSH).
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Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 29, 2021
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
November 30, 2021
First Submitted That Met QC Criteria
December 13, 2021
First Posted (Actual)
December 29, 2021
Study Record Updates
Last Update Posted (Actual)
October 13, 2022
Last Update Submitted That Met QC Criteria
October 10, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00001052-21109
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.
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