NCT00809432

Brief Summary

Exposure to air pollution is an important risk factor for cardiovascular morbidity and mortality, and is associated with increased blood pressure, reduced heart rate variability, endothelial dysfunction and myocardial ischaemia. The study objectives were to assess the potential cardiovascular benefits of reducing personal particulate air pollution exposure by wearing a facemask in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
Last Updated

December 17, 2008

Status Verified

December 1, 2008

Enrollment Period

Same day

First QC Date

December 15, 2008

Last Update Submit

December 15, 2008

Conditions

Keywords

Air pollutionHeart rateHeart rate variabilityBlood pressureFace mask

Outcome Measures

Primary Outcomes (1)

  • Ambulatory blood pressure

    During 24 hour study period

Secondary Outcomes (3)

  • Heart rate

    During 24 hour study period

  • Heart rate variability

    During 24 hour study period

  • Personal air pollution exposure

    During 2 hour city centre walk

Study Arms (2)

Visit 1

EXPERIMENTAL

2 hour city centre kerbside walk in Beijing China

Other: No Face mask

Visit 2

EXPERIMENTAL

2 hour city centre kerbside walk in Beijing China

Device: Face mask (Dust Respirator)

Interventions

Subjects to wear a simple face mask for 24 hours prior to the study day and the 24 hours of the study day. They will be instructed to wear the mask as much as possible when indoors and at all times when outdoors.

Also known as: 3M Dust Respirator 8812
Visit 2

Subjects will not wear a face mask to reduce their personal exposure to air pollution

Visit 1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers

You may not qualify if:

  • Current smokers
  • Significant occupational exposure to air pollution
  • Regular medication use (except oral contraceptive pill)
  • Intercurrent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Medical Union College

Beijing, China

Location

Related Publications (1)

  • Langrish JP, Watts SJ, Hunter AJ, Shah AS, Bosson JA, Unosson J, Barath S, Lundback M, Cassee FR, Donaldson K, Sandstrom T, Blomberg A, Newby DE, Mills NL. Controlled exposures to air pollutants and risk of cardiac arrhythmia. Environ Health Perspect. 2014 Jul;122(7):747-53. doi: 10.1289/ehp.1307337. Epub 2014 Mar 25.

MeSH Terms

Interventions

Masks

Intervention Hierarchy (Ancestors)

Surgical AttireEquipment and Supplies, HospitalEquipment and SuppliesProtective DevicesPersonal Protective EquipmentSurgical EquipmentManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Jeremy P Langrish, MB BCh MRCP

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 17, 2008

Study Start

August 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 17, 2008

Record last verified: 2008-12

Locations