Clinical trial NCT02238028: Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators
Official title: Short-term Cardiovascular Benefits of Wearing Particulate-filtering Respirators: a Randomized Controlled Crossover Trial Among Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Nervous System Imbalance
Blood Pressure
Inflammation
Vasoconstriction
Blood Coagulation Disorders
Keywords: Heart rate variability
Blood pressure
Circulating biomarkers
Respirator
Fine particulate matter
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Heart Rate Variability-LF Power,HF Power,VLF Power
timeFrame: up to 24 hours
measure: Blood Pressure
timeFrame: up to 24 hours
measure: Heart Rate Variability-SDNN,SDANN, rMSSD
timeFrame: Up to 24 hours
measure: Heart Rate Variability-LF/HF
timeFrame: Up to 24 hours
measure: Heart Rate Variability-pNN50
timeFrame: Up to 24 hours
measure: Circulating Biomarkers--Fibrinogen，vWF
timeFrame: Up to 24 hours
measure: Circulating Biomarkers--P- Selectin,VCAM-1
timeFrame: Up to 24 hours
measure: Circulating Biomarkers--ET-1
timeFrame: Up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: School of Public Health，Fudan University
name: Kan Haidong, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.