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An intervention study to assess the short-term cardiovascular effects of reducing personal air pollution exposure by wearing particulate filtering respirators.
A group of healthy adult college students fulfilling the recruitment criteria were randomly divided into two sub-groups. One sub-group weared the particulate filtering respirators for 2 continuous days during which the respirator was required to wear as much as possible both indoor and outdoor. The other group acted as normal at the same time. The measurements on health effects including heart rate varibility, blood pressure, circulating biomarkers as well as the ambient air pollution were performed in both groups during the intervention period. After a 3-week rest period,the two groups interchanged their roles of wearing the respirator or not. The same measurements of both health effects indicators and ambient air pollution were repeated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wear respirator | Experimental | The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. |
|
| Not wear respirator | No Intervention | The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wear respirator | Behavioral | Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability-LF Power,HF Power,VLF Power | HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences. | up to 24 hours |
| Blood Pressure | The blood pressure were measured by automatic blood pressure monitor during the intervention study. | up to 24 hours |
| Heart Rate Variability-SDNN,SDANN, rMSSD | HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention. | Up to 24 hours |
| Heart Rate Variability-LF/HF | HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kan Haidong, PhD | School of Public Health，Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23849322 | Background | Shah AS, Langrish JP, Nair H, McAllister DA, Hunter AL, Donaldson K, Newby DE, Mills NL. Global association of air pollution and heart failure: a systematic review and meta-analysis. Lancet. 2013 Sep 21;382(9897):1039-48. doi: 10.1016/S0140-6736(13)60898-3. Epub 2013 Jul 10. | |
| 26022815 | Background | Chen R, Zhao A, Chen H, Zhao Z, Cai J, Wang C, Yang C, Li H, Xu X, Ha S, Li T, Kan H. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers. J Am Coll Cardiol. 2015 Jun 2;65(21):2279-87. doi: 10.1016/j.jacc.2015.03.553. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Wearing Respirator First,Then Not Wearing Respirator | The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor. |
| FG001 | Not Wearing Respirator First,Then Wearing Respirator | The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days including a 2-hour walking along the streets on the 2nd day along a fixed route. After a 2-week rest period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days including the 2-hour walking along the streets on the 2nd day along the same fixed route. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate Variability-LF Power,HF Power,VLF Power | HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences. | Posted | Geometric Mean | Standard Deviation | ms^2 | up to 24 hours |
|
At the end of each 2-day period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Wear Respirator | The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Haidong Kan | Fudan University | +86-021-54237908 | kanh@fudan.edu.cn |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D001778 | Blood Coagulation Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| Up to 24 hours |
| Heart Rate Variability-pNN50 | HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention. | Up to 24 hours |
| Circulating Biomarkers--Fibrinogen，vWF | At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts) | Up to 24 hours |
| Circulating Biomarkers--P- Selectin,VCAM-1 | At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts) | Up to 24 hours |
| Circulating Biomarkers--ET-1 | At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays. | Up to 24 hours |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| systolic pressure | Mean | Standard Deviation | mmHg |
|
| diastolic pressure | Mean | Standard Deviation | mmHg |
|
| Wear Respirator |
The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor. |
| OG001 | Not Wear Respirator | The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. |
|
|
|
| Primary | Blood Pressure | The blood pressure were measured by automatic blood pressure monitor during the intervention study. | Posted | Mean | Standard Deviation | mmHg | up to 24 hours |
|
|
|
|
| Primary | Heart Rate Variability-SDNN,SDANN, rMSSD | HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the standard deviation of the normal-to-normal interval(SDNN),the standard deviation of the average NN intervals calculated over short periods(SDANN), the root mean square of the successive differences(rMSSD) were automatically recorded during the intervention. | Posted | Geometric Mean | Standard Deviation | ms | Up to 24 hours |
|
|
|
| Primary | Heart Rate Variability-LF/HF | HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Frequency domain methods assign bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz. Parasympathetic activity is a major contributor to the HF component. More problematic is the interpretation of the LF component, which was considered by some as a marker of sympathetic modulation but is now known to include both sympathetic and vagal influences. | Posted | Geometric Mean | Standard Deviation | ratio | Up to 24 hours |
|
|
|
| Primary | Heart Rate Variability-pNN50 | HRV is a quantitative health marker reflecting how the autonomic nervous system modulates the sinoatrial node in the heart and HRV has therefore been widely used to estimate cardiac autonomic function and control.A total of 8 parameters of HRV were analyzed including 4 time-domain indices and 4 frequency-domain indices. Subjects were attached with Holter monitor on the 2nd day in each of the 48-hr intervention period. Heart rate and heart automatic function indices including the proportion of successive normal NN intervals differing by more than 50 ms in the total number of NNs（pNN50） were automatically recorded during the intervention. | Posted | Geometric Mean | Standard Deviation | percentage of ms | Up to 24 hours |
|
|
|
| Primary | Circulating Biomarkers--Fibrinogen，vWF | At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Fibrinogen and von Willebrand factor(vWF) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts) | Posted | Geometric Mean | Standard Deviation | µg/ml | Up to 24 hours |
|
|
|
| Primary | Circulating Biomarkers--P- Selectin,VCAM-1 | At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. P- selectin,VCAM-1(vascular cell adhesion molecule-1) were measured by using the Millipore MILLIPLEX MAP human cytokine/chemokine kit (Millipore Corp., Billerica, Massachusetts) | Posted | Geometric Mean | Standard Deviation | ng/ml | Up to 24 hours |
|
|
|
| Primary | Circulating Biomarkers--ET-1 | At the end of each intervention, participants were asked to rest in a quiet room for half an hour. Peripheral venous blood samples were collected and centrifuged immediately. The serum were collected and stored at -80℃ within 30 minutes to minimize the in-vitro changes in biomarker proteins. Endothelin-1(ET-1) was using enzyme-linked immunosorbent assays. | Posted | Geometric Mean | Standard Deviation | pg/ml | Up to 24 hours |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Not Wear Respirator | The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period. | 0 | 24 | 0 | 24 |
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| Title | Measurements |
|---|---|
|