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

April 7, 2016 updated by: Feng Li, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201620
        • Shanghai First People's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Within 2h after the filtration intervention
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).
Within 2h after the filtration intervention
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.
Within 2h after the filtration intervention
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.
6h after filtration intervention
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).
Within 2h after the filtration intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At 0h after the filtration intervention
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.
6h after filtration intervention
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.
24h after filtration intervention
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.
Within 1h after filtration intervention
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.
24h after filtration intervention
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
On the first night and the second night of study participation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University
Rutgers University
Tsinghua University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015[38]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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