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Completed

NCT Number: NCT02238028

Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators

An intervention study to assess the short-term cardiovascular effects of reducing personal air pollution exposure by wearing particulate filtering respirators.

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Key information

Conditions

Autonomic Nervous System Imbalance Blood Coagulation Disorders Blood Pressure Hematologic Diseases Hemic and Lymphatic Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Vasoconstriction

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Equal to or older than 18 years old,
  • No history of smoking and alcohol addiction.
  • No chronic diseases,such as hypertension,diabetes,chronic obstructive pulmonary disease or other respiratory/cardiovascular diseases reported by volunteers.
  • No respiratory or allergic diseases, like asthma, rhinitis,or other allergic diseases.

Exclusion criteria

  • Current smokers
  • Chronic drug use due on cardiovascular or respiratory diseases

Treatment and study plan

Wear respirator

Behavioral

Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.

Other names: particulate filtering respirator

Primary outcomes

  1. Heart Rate Variability-LF Power,HF Power,VLF Power

    Time frame: up to 24 hours

    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.

  2. Blood Pressure

    Time frame: up to 24 hours

    The blood pressure were measured by automatic blood pressure monitor during the intervention study.

  3. Heart Rate Variability-SDNN,SDANN, rMSSD

    Time frame: Up to 24 hours

    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.

  4. Heart Rate Variability-LF/HF

    Time frame: Up to 24 hours

    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.

  5. Heart Rate Variability-pNN50

    Time frame: Up to 24 hours

    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.

  6. Circulating Biomarkers--Fibrinogen，vWF

    Time frame: Up to 24 hours

    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)

  7. Circulating Biomarkers--P- Selectin,VCAM-1

    Time frame: Up to 24 hours

    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)

  8. Circulating Biomarkers--ET-1

    Time frame: Up to 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators: a Randomized Controlled Crossover Trial Among Healthy Young Adults

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 12, 2014
Registry last updated
May 6, 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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