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Completed

NCT Number: NCT02736487

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

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.

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Key information

Conditions

Non-smoking, Healthy Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 201620, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

True-Washout-Sham Air Filtration Intervention

Device

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.

Sham-Washout-True Air Filtration Intervention

Device

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Duke University
  • Rutgers University
  • Tsinghua University

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 13, 2016
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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