Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Short-term Portable Air Purifier Use on Occupant Health Indicators

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02736487
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Collaborators:
Duke University
Tsinghua University
Rutgers University
Information provided by (Responsible Party):
Feng Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The purpose of this research project is to examine whether short-term use of portable air pollution filtration can result in changes in indoor airborne pollutants and impact on cardiovascular and respiratory health outcomes of the inhabitants.

Condition or disease Intervention/treatment Phase
Non-smoking, Healthy Adults Device: True-Washout-Sham Air Filtration Intervention Device: Sham-Washout-True Air Filtration Intervention Not Applicable

Detailed Description:
This study will focus on evaluating the short-term benefits of a common portable air purifier technology in reducing air pollutant exposure and the anticipated concomitant health impacts. High ambient levels of various air pollutants in the Shanghai area serve as a useful model to test the portable air purifier intervention in a realistic setting. As most people using a portable air purifier would only be able to do so in their residences, the investigators have designed our study only to test residential air purifier use. Our hypothesis is that the reduction in pollutant concentrations in indoor air caused by the air purifier will result in measurable reductions in risk factors for cardiovascular and respiratory diseases.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Short-term Portable Air Purifier Use on Occupant Health Indicators
Study Start Date : November 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: Group A: True-Washout-Sham
Subjects in group A receives true air filtration intervention, then at least two weeks of washout period, followed by sham air filtration intervention.
Device: True-Washout-Sham Air Filtration Intervention
This intervention involved three sequential steps: (1) 12 to 20 hours of true air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of sham air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented.

Active Comparator: Group B: Sham-Washout-True
Subjects in group B receives sham air filtration intervention, then at least two weeks of washout period, followed by true air filtration intervention.
Device: Sham-Washout-True Air Filtration Intervention
This intervention involved three sequential steps: (1) 12 to 20 hours of sham air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of true air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented.




Primary Outcome Measures :
  1. Change from baseline FEV1 (forced expiratory volume in the first second of exhalation) within 2h after the filtration intervention [ Time Frame: Within 2h after the filtration intervention ]
    FEV1 (forced expiratory volume in the first second of exhalation, unit: liter) was measured by spirometry in all subjects within 2h after the filtration intervention to compare to FEV1 value of study subjects at baseline (i.e. at start of the study).

  2. Change from baseline R5 (airway resistance measured at 5Hz) within 2h after the filtration intervention [ Time Frame: Within 2h after the filtration intervention ]
    R5 (airway resistance measured at 5Hz) was accessed by impulse oscillometry in all subjects within 2h after the filtration intervention to compare to the R5 value of study subjects at baseline (i.e. before the start of intervention).

  3. Change in baseline exhaled nitric oxide (eNO) within 2h after the filtration intervention [ Time Frame: Within 2h after the filtration intervention ]
    Exhaled nitric oxide (eNO) was measured in all subjects within 2h after the filtration intervention to compare to the exhaled nitric oxide measurement of study subjects at baseline (i.e. before the start of intervention). Exhaled breath is collected in air sampling bags, and the concentration of NO was quantified by Thermo Scientific model 42i (NO-NO2-NOx) analyzer.

  4. Change in exhaled nitric oxide (eNO) at 6h after filtration intervention compared to baseline [ Time Frame: 6h after filtration intervention ]
    Exhaled nitric oxide (eNO) was measured in all subjects 6h after filtration intervention to compare to the exhaled nitric oxide measurement of study subjects at baseline (i.e. before the start of intervention). Exhaled breath is collected in air sampling bags, and the concentration of NO was quantified by Thermo Scientific model 42i (NO-NO2-NOx) analyzer.

  5. Change from baseline PWV (pulse wave velocity) within 2h after the filtration intervention [ Time Frame: Within 2h after the filtration intervention ]
    PWV (pulse wave velocity) was measured by the VICORDER instrument in all subjects right after filtration intervention to compare to the PWV value measured at baseline (i.e. before the start of intervention).


Secondary Outcome Measures :
  1. Change from baseline urinary biomarkers of inflammation and oxidative stress at 0h after the filtration intervention [ Time Frame: At 0h after the filtration intervention ]
    Urine samples were collected from each subject at 0h after the filtration intervention to quantify changes in urinary oxidative stress and inflammation biomarkers compared to baseline (i.e. before intervention). The urinary biomarkers to be analyzed include: malondialdehyde (MDA), 8-hydroxy-2' -deoxyguanosine (8-OHdG) and creatinine. The unit of the urinary biomarkers will be reported as micro molar/ milliliter.

  2. Change in baseline urinary biomarkers of inflammation and oxidative stress at 6h after filtration intervention [ Time Frame: 6h after filtration intervention ]
    Urine samples were collected from each subject at 6h after filtration intervention to quantify changes in urinary oxidative stress and inflammation biomarkers compared to baseline (i.e. before intervention). The urinary biomarkers to be analyzed include: malondialdehyde (MDA), 8-hydroxy-2' -deoxyguanosine (8-OHdG) and creatinine. The unit of the urinary biomarkers will be reported as micro molar/ milliliter.

  3. Change in baseline urinary biomarkers of inflammation and oxidative stress at 24h after filtration intervention [ Time Frame: 24h after filtration intervention ]
    Urine samples were collected from each subject at 24h after filtration intervention to quantify changes in urinary oxidative stress and inflammation biomarkers compared to baseline (i.e. before intervention). The urinary biomarkers to be analyzed include: malondialdehyde (MDA), 8-hydroxy-2' -deoxyguanosine (8-OHdG) and creatinine. The unit of the urinary biomarkers will be reported as micro molar/ milliliter.

  4. Changes in baseline blood biomarkers of inflammation, oxidative stress and coagulation within 1h after filtration intervention [ Time Frame: Within 1h after filtration intervention ]
    Blood samples were collected within 1h after filtration intervention for comparison of inflammatory and oxidative stress biomarkers to their baseline level (i.e. before the start of filtration intervention). Blood biomarkers that will be analyzed include: P-selectin, c-reactive protein, Von Willebrand factor and fibrinogen. The unit of the blood biomarkers will be reported as micro molar/ milliliter.

  5. Changes in baseline blood biomarkers of inflammation, oxidative stress and coagulation right after filtration intervention [ Time Frame: 24h after filtration intervention ]
    Blood samples were collected 24h after filtration intervention for comparison of inflammatory and oxidative stress biomarkers to their baseline level (i.e. before the start of filtration intervention). Blood biomarkers that will be analyzed include: P-selectin, c-reactive protein, Von Willebrand factor and fibrinogen. The unit of the blood biomarkers will be reported as micro molar/ milliliter.

  6. Change in the duration of deep sleep on the first night and the second night of study participation [ Time Frame: On the first night and the second night of study participation ]
    Duration of deep sleep was monitored by a sensor in a wristband on the first night and the second night of study participation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, non-smoking adults
  • Live in the dormitory building at Shanghai First People's Hospital (South Section).

Exclusion Criteria:

  • Current smokers
  • Has any of the following diseases: chronic respiratory, cardiovascular, liver, renal, hematological disease; diabetes mellitus;
  • Has any other diseases that may confound or complicate the effects of the intervention
  • Pregnant females

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736487


Locations
Layout table for location information
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 201620
Sponsors and Collaborators
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Duke University
Tsinghua University
Rutgers University
Investigators
Layout table for investigator information
Principal Investigator: Junfeng Zhang, PhD Duke University
Principal Investigator: Yinping Zhang, PhD Tsinghua University

Layout table for additonal information
Responsible Party: Feng Li, MD, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02736487     History of Changes
Other Study ID Numbers: 2015[38]
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Feng Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine:
Air Pollution
Exposure Assessment
Filtration
Cardiovascular Outcomes
Respiratory Outcomes
Short-term Intervention