Blood PressureNCT00809432
The Cardiovascular Benefits of Reducing Personal Exposure to Air Pollution
A study testing Face mask (Dust Respirator) and No Face mask in people with Blood Pressure and Heart Rate Variability, run by University of Edinburgh at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Heart Rate Variability
- What is being tested?
- Face mask (Dust Respirator) and No Face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Current smokers
- Significant occupational exposure to air pollution
- Regular medication use (except oral contraceptive pill)
- Intercurrent illness
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences & Peking Medical Union College
Beijing
About this study
Official title: Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask
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.
- Conditions
- Blood Pressure, Heart Rate Variability
- Being tested
- Face mask (Dust Respirator), No Face mask
- Keywords
- Air pollution, Heart rate, Heart rate variability, Blood pressure, Face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face mask (Dust Respirator)Device
Also called 3M Dust Respirator 8812
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.
No Face maskOther
Subjects will not wear a face mask to reduce their personal exposure to air pollution
| Study group | Role | What they receive |
|---|---|---|
| Visit 1 | Experimental | 2 hour city centre kerbside walk in Beijing China Receives: Other: No Face mask |
| Visit 2 | Experimental | 2 hour city centre kerbside walk in Beijing China Receives: Device: Face mask (Dust Respirator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory blood pressure
Measured: During 24 hour study period
Secondary outcomes (3)
Heart rate
Measured: During 24 hour study period
Heart rate variability
Measured: During 24 hour study period
Personal air pollution exposure
Measured: During 2 hour city centre walk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College
- Investigators
- Jeremy P Langrish, MB BCh MRCP, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809432
- Sponsor's protocol ID
- 167/2008/Pilot
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 17 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24667535
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Cardiovascular Effects of Reducing Exposure to Particulate Air Pollution With a Simple Facemask
- ClinicalTrials.gov ID
- NCT00809432
- Acronym / sponsor ID
- 167/2008/Pilot
- Conditions
- Blood Pressure, Heart Rate Variability
- Keywords
- Air pollution, Heart rate, Heart rate variability, Blood pressure, Face mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Peking Union Medical College
- Study start
- Aug 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visit 1 | Experimental | Other: No Face mask2 hour city centre kerbside walk in Beijing China |
| Visit 2 | Experimental | Device: Face mask (Dust Respirator)2 hour city centre kerbside walk in Beijing China |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (4 listed)
- Current smokers
- Significant occupational exposure to air pollution
- Regular medication use (except oral contraceptive pill)
- Intercurrent illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face mask (Dust Respirator)Also: 3M Dust Respirator 8812Subjects 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. | Device | Visit 2 |
| No Face maskSubjects will not wear a face mask to reduce their personal exposure to air pollution | Other | Visit 1 |
Primary outcome
Ambulatory blood pressure
Time frame: During 24 hour study period
3 secondary outcomes
Heart rate
Time frame: During 24 hour study period
Heart rate variability
Time frame: During 24 hour study period
Personal air pollution exposure
Time frame: During 2 hour city centre walk
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2008.
- Derived from this study: PubMed 24667535Langrish 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy P Langrish, MB BCh MRCP principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face mask (Dust Respirator) and No Face mask in people with Blood Pressure and Heart Rate Variability, run by University of Edinburgh at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory blood pressure (time frame: During 24 hour study period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00809432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2008; AzTrials last refreshed its copy on 8 Nov 2026.