Trial Outcomes & Findings for Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators (NCT NCT02238028)
NCT ID: NCT02238028
Last Updated: 2016-05-06
Results Overview
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.
COMPLETED
NA
28 participants
up to 24 hours
2016-05-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
24 participants
n=5 Participants
|
|
BMI
|
22 kg/m^2
STANDARD_DEVIATION 4 • n=5 Participants
|
|
systolic pressure
|
108 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
|
diastolic pressure
|
70 mmHg
STANDARD_DEVIATION 5 • n=5 Participants
|
PRIMARY outcome
Timeframe: up to 24 hoursHRV 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.
Outcome measures
| Measure |
Wear Respirator
n=24 Participants
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.
|
Not Wear Respirator
n=24 Participants
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.
|
|---|---|---|
|
Heart Rate Variability-LF Power,HF Power,VLF Power
low frequency(LF) power
|
899.4 ms^2
Standard Deviation 601.3
|
838.5 ms^2
Standard Deviation 562.4
|
|
Heart Rate Variability-LF Power,HF Power,VLF Power
high frequency(HF) power
|
519.7 ms^2
Standard Deviation 371.0
|
416.6 ms^2
Standard Deviation 296.6
|
|
Heart Rate Variability-LF Power,HF Power,VLF Power
very low frequency(VLF) power
|
1684.6 ms^2
Standard Deviation 875.7
|
1623.1 ms^2
Standard Deviation 1006.5
|
PRIMARY outcome
Timeframe: up to 24 hoursThe blood pressure were measured by automatic blood pressure monitor during the intervention study.
Outcome measures
| Measure |
Wear Respirator
n=24 Participants
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.
|
Not Wear Respirator
n=24 Participants
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.
|
|---|---|---|
|
Blood Pressure
systolic blood pressure
|
107.3 mmHg
Standard Deviation 8.0
|
109.0 mmHg
Standard Deviation 7.4
|
|
Blood Pressure
diastolic blood pressure
|
70.0 mmHg
Standard Deviation 5.0
|
70.8 mmHg
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Up to 24 hoursHRV 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.
Outcome measures
| Measure |
Wear Respirator
n=24 Participants
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.
|
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.
|
|---|---|---|
|
Heart Rate Variability-SDNN,SDANN, rMSSD
SDNN
|
177.5 ms
Standard Deviation 29.9
|
—
|
|
Heart Rate Variability-SDNN,SDANN, rMSSD
SDANN
|
160.7 ms
Standard Deviation 28.9
|
—
|
|
Heart Rate Variability-SDNN,SDANN, rMSSD
rMSSD
|
49.0 ms
Standard Deviation 13.3
|
—
|
PRIMARY outcome
Timeframe: Up to 24 hoursHRV 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.
Outcome measures
| Measure |
Wear Respirator
n=24 Participants
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.
|
Not Wear Respirator
n=24 Participants
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.
|
|---|---|---|
|
Heart Rate Variability-LF/HF
|
1.4 ratio
Standard Deviation 0.3
|
1.5 ratio
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Up to 24 hoursHRV 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.
Outcome measures
| Measure |
Wear Respirator
n=24 Participants
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.
|
Not Wear Respirator
n=24 Participants
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.
|
|---|---|---|
|
Heart Rate Variability-pNN50
|
24.0 percentage of ms
Standard Deviation 9.9
|
20.5 percentage of ms
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: Up to 24 hoursAt 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)
Outcome measures
| Measure |
Wear Respirator
n=24 Participants
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.
|
Not Wear Respirator
n=24 Participants
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.
|
|---|---|---|
|
Circulating Biomarkers--Fibrinogen，vWF
Fibrinogen
|
2.5 µg/ml
Standard Deviation 1.3
|
2.5 µg/ml
Standard Deviation 1.3
|
|
Circulating Biomarkers--Fibrinogen，vWF
vWF
|
24.5 µg/ml
Standard Deviation 1.3
|
27.1 µg/ml
Standard Deviation 1.3
|
PRIMARY outcome
Timeframe: Up to 24 hoursAt 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)
Outcome measures
| Measure |
Wear Respirator
n=24 Participants
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.
|
Not Wear Respirator
n=24 Participants
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.
|
|---|---|---|
|
Circulating Biomarkers--P- Selectin,VCAM-1
P-selectin
|
164.0 ng/ml
Standard Deviation 2.0
|
200.3 ng/ml
Standard Deviation 1.5
|
|
Circulating Biomarkers--P- Selectin,VCAM-1
VCAM-1
|
1480.3 ng/ml
Standard Deviation 1.5
|
1808.0 ng/ml
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: Up to 24 hoursAt 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.
Outcome measures
| Measure |
Wear Respirator
n=24 Participants
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.
|
Not Wear Respirator
n=24 Participants
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.
|
|---|---|---|
|
Circulating Biomarkers--ET-1
|
109.9 pg/ml
Standard Deviation 1.6
|
121.5 pg/ml
Standard Deviation 1.6
|
Adverse Events
Wear Respirator
Not Wear Respirator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place