Indoor Air Filtration and Young Adults Health Study
Primary Purpose
Cardiopulmonary Diseases
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Air purifier
Sponsored by
About this trial
This is an interventional prevention trial for Cardiopulmonary Diseases
Eligibility Criteria
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.
Sites / Locations
- Peking University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Real purification
Sham purification
Arm Description
Air purifier turned on.
Air purifier turned off.
Outcomes
Primary Outcome Measures
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.
Changes in blood pressure
Including the systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, and pulse pressure (PP) in mmHg.
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.
Secondary Outcome Measures
Changes in levels of airway inflammation
Respiratory inflammation Fractional exhaled nitric oxide (FeNO) test would be conducted.
Changes in levels of C-reactive protein (CRP)
Examining the C-reactive protein (CRP) in blood sample to characterize the levels of inflammation.
Changes in levels of 8-hydroxydeoxyguanosine (8-OHdG)
Examining the 8-hydroxydeoxyguanosine (8-OHdG) in urine sample to characterize the levels of oxidative stress.
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.
Changes in levels of sleep-breathing parameters
Including blood oxygen saturation in percentage and heart rate in bpm.
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.
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.
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.
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.
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).
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).
Changes in levels of microbiomics in nasal mucus
Nasal mucus samples were collected for microbiomics analysis to examine the microbial community abundance (α-diversity).
Changes in levels of microbiomics in EBC
EBC samples were collected for microbiomics analysis to examine the microbial community abundance (α-diversity).
Changes in levels of pituitary-related hormones
Including serum levels of cortisol, adreno-cortico-tropic-hormone (ACTH), and thyroid stimulating hormone (TSH).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05172388
Brief Title
Indoor Air Filtration and Young Adults Health Study
Official Title
Cardiopulmonary Health Effects of Indoor Air Purification and Other Indoor Environmental Conditions Among Young Healthy Adults in Beijing, China
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiopulmonary Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real purification
Arm Type
Active Comparator
Arm Description
Air purifier turned on.
Arm Title
Sham purification
Arm Type
Sham Comparator
Arm Description
Air purifier turned off.
Intervention Type
Other
Intervention Name(s)
Air purifier
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in heart rate variability
Description
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.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in blood pressure
Description
Including the systolic blood pressure (SBP) in mmHg, diastolic blood pressure (DBP) in mmHg, and pulse pressure (PP) in mmHg.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in pulmonary function
Description
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.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Secondary Outcome Measure Information:
Title
Changes in levels of airway inflammation
Description
Respiratory inflammation Fractional exhaled nitric oxide (FeNO) test would be conducted.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of C-reactive protein (CRP)
Description
Examining the C-reactive protein (CRP) in blood sample to characterize the levels of inflammation.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of 8-hydroxydeoxyguanosine (8-OHdG)
Description
Examining the 8-hydroxydeoxyguanosine (8-OHdG) in urine sample to characterize the levels of oxidative stress.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of sleep-related parameters
Description
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.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of sleep-breathing parameters
Description
Including blood oxygen saturation in percentage and heart rate in bpm.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of cognitive function
Description
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.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of cognitive function-related biomarkers
Description
Including serum brain derived nerve factor (BDNF) in ng/mL, S100B protein in ng/mL, and neuron-specific-enolase (NSE) in ng/mL.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of blood cell parameters
Description
Including white blood cells in unit, red blood cells in unit, and platelets in unit measured by blood routine examination.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of systematic inflammation and oxidative stress indicators
Description
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.
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of glucose metabolites in serum
Description
Serum samples were collected for targetted glucose metabolomics analysis using the gas chromatography and mass spectrometry (GC-MS).
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of neurotransmitter metabolites in serum
Description
Serum samples were collected for targetted neurotransmitter metabolomics analysis using the gas chromatography and mass spectrometry (GC-MS).
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of microbiomics in nasal mucus
Description
Nasal mucus samples were collected for microbiomics analysis to examine the microbial community abundance (α-diversity).
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of microbiomics in EBC
Description
EBC samples were collected for microbiomics analysis to examine the microbial community abundance (α-diversity).
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
Title
Changes in levels of pituitary-related hormones
Description
Including serum levels of cortisol, adreno-cortico-tropic-hormone (ACTH), and thyroid stimulating hormone (TSH).
Time Frame
Baseline and after the completion of intervention period (a 4-day real purifier intervention or a 4-day sham purifier intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking University
City
Beijing
ZIP/Postal Code
100191
Country
China
12. IPD Sharing Statement
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Indoor Air Filtration and Young Adults Health Study
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