Cardiovascular Diseases in Old AgeNCT03334565
Reducing PM-associated CV Health Effects for Seniors
A study testing Low efficiency air filtration systems and High efficiency air filtration systems in people with Cardiovascular Diseases in Old Age, run by Michigan State University.
Trial summary
The objective of this study is to investigate the effectiveness of air filtration at reducing personal-level exposures to fine particulate matter (PM2.5) and mitigating related cardiovascular (CV) health effects among older adults in a residential facility in a representative US urban location. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases in Old Age
- What is being tested?
- Low efficiency air filtration systems and High efficiency air filtration systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 21 Oct 2014to 4 Nov 2016
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 to 85 years old
- non-smoking healthy adults
Who cannot join
- smoke or anyone in your residence smokes.
- had a cardiovascular event within the past 6 months (such as myocardial infarction (heart attack), angina, cardiac or carotid surgery or stent, diagnosed peripheral arterial disease, aortic aneurysms, treated heart failure, any treated arrhythmia including atrial fibrillation)
- have renal disease requiring dialysis.
- have had medication changes in the past 6 weeks.
- use supplementary oxygen.
About this study
Official title: Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
The objective of this study is to investigate the effectiveness of air filtration at reducing personal-level exposures to fine particulate matter (PM2.5) and mitigating related cardiovascular (CV) health effects among older adults in a residential facility in a representative US urban location.
We enrolled 40 nonsmoking older adults into a randomized double-blind crossover intervention study with daily CV health outcomes and PM2.5 exposure measurements. The study was conducted in a low-income senior living apartment building in downtown Detroit, Michigan.
Read more
Participants were exposed to three 3-day scenarios separated by one-week washout periods: unfiltered ambient air (control), low-efficiency (LE) "HEPA-type", and high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.
The primary outcome was brachial blood pressure (BP). Secondary outcomes included noninvasive aortic hemodynamics and pulse wave velocity and heart rate variability. PM2.5 exposures were measured in the participants' residences as well as by personal-level monitoring.
- Conditions
- Cardiovascular Diseases in Old Age
- Being tested
- Low efficiency air filtration systems, High efficiency air filtration systems, Air filtration systems without filters (sham)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low efficiency air filtration systemsDevice
Subjects were exposed to low-efficiency filtered air.
High efficiency air filtration systemsDevice
Subjects were exposed to high-efficiency filtered air.
Air filtration systems without filters (sham)Device
Subjects were exposed to unfiltered air.
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Participants were exposed to unfiltered ambient air (sham) filtered air using air filtration systems in the bedroom and main living space of each residence. Receives: Device: Air filtration systems without filters (sham) |
| Low efficiency | Active comparator | Participants were exposed to low-efficiency (LE) "HEPA-type" filtered air using air filtration systems in the bedroom and main living space of each residence. Receives: Device: Low efficiency air filtration systems |
| High efficiency | Active comparator | Participants were exposed to high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence. Receives: Device: High efficiency air filtration systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
brachial blood pressure
Brachial blood pressure was measured using a BPTru device.
Measured: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Secondary outcomes (4)
noninvasive aortic hemodynamics
Aortic hemodynamics was measured using a SphygmoCor device.
Measured: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Pulse wave velocity
Pulse wave velocity was measured using a SphygmoCor device.
Measured: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
heart rate variability
Heart rate variability was measured using a SphygmoCor device.
Measured: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
microvasculature tone
Retinal photography was used to measure retinal arteriole diameters.
Measured: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start21 Oct 2014
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
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 Cardiovascular Diseases in Old AgeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Masako Morishita, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334565
- Sponsor's protocol ID
- R01NR014484
- Status last verified
- Oct 2020
- First submitted
- 3 Nov 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morishita M, Adar SD, D'Souza J, Ziemba RA, Bard RL, Spino C, Brook RD. Effect of Portable Air Filtration Systems on Personal Exposure to Fine Particulate Matter and Blood Pressure Among Residents in a Low-Income Senior Facility: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1350-1357. doi: 10.1001/jamainternmed.2018.3308.
PubMed 30208394
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
- ClinicalTrials.gov ID
- NCT03334565
- Acronym / sponsor ID
- R01NR014484
- Conditions
- Cardiovascular Diseases in Old Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 21 Oct 2014 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 7 Nov 2017 (actual)
- 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.
The objective of this study is to investigate the effectiveness of air filtration at reducing personal-level exposures to fine particulate matter (PM2.5) and mitigating related cardiovascular (CV) health effects among older adults in a residential facility in a representative US urban location.
We enrolled 40 nonsmoking older adults into a randomized double-blind crossover intervention study with daily CV health outcomes and PM2.5 exposure measurements. The study was conducted in a low-income senior living apartment building in downtown Detroit, Michigan.
Participants were exposed to three 3-day scenarios separated by one-week washout periods: unfiltered ambient air (control), low-efficiency (LE) "HEPA-type", and high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence.
The primary outcome was brachial blood pressure (BP). Secondary outcomes included noninvasive aortic hemodynamics and pulse wave velocity and heart rate variability. PM2.5 exposures were measured in the participants' residences as well as by personal-level monitoring.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Air filtration systems without filters (sham)Participants were exposed to unfiltered ambient air (sham) filtered air using air filtration systems in the bedroom and main living space of each residence. |
| Low efficiency | Active comparator | Device: Low efficiency air filtration systemsParticipants were exposed to low-efficiency (LE) "HEPA-type" filtered air using air filtration systems in the bedroom and main living space of each residence. |
| High efficiency | Active comparator | Device: High efficiency air filtration systemsParticipants were exposed to high-efficiency (HE) "true-HEPA" filtered air using air filtration systems in the bedroom and main living space of each residence. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50 to 85 years old
- non-smoking healthy adults
Key exclusion criteria (5 listed)
- smoke or anyone in your residence smokes.
- had a cardiovascular event within the past 6 months (such as myocardial infarction (heart attack), angina, cardiac or carotid surgery or stent, diagnosed peripheral arterial disease, aortic aneurysms, treated heart failure, any treated arrhythmia including atrial fibrillation)
- have renal disease requiring dialysis.
- have had medication changes in the past 6 weeks.
- use supplementary oxygen.
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 |
|---|---|---|
| Low efficiency air filtration systemsSubjects were exposed to low-efficiency filtered air. | Device | Low efficiency |
| High efficiency air filtration systemsSubjects were exposed to high-efficiency filtered air. | Device | High efficiency |
| Air filtration systems without filters (sham)Subjects were exposed to unfiltered air. | Device | Sham |
Primary outcome
brachial blood pressure
Time frame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Brachial blood pressure was measured using a BPTru device.
4 secondary outcomes
noninvasive aortic hemodynamics
Time frame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
Pulse wave velocity
Time frame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
heart rate variability
Time frame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
microvasculature tone
Time frame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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 22 Oct 2020.
- Derived from this study: PubMed 30208394Morishita M, Adar SD, D'Souza J, Ziemba RA, Bard RL, Spino C, Brook RD. Effect of Portable Air Filtration Systems on Personal Exposure to Fine Particulate Matter and Blood Pressure Among Residents in a Low-Income Senior Facility: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1350-1357. doi: 10.1001/jamainternmed.2018.3308.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low efficiency air filtration systems and High efficiency air filtration systems in people with Cardiovascular Diseases in Old Age, run by Michigan State University.
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 2 inclusion and 5 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
brachial blood pressure (time frame: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement). 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 NCT03334565, 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 22 Oct 2020.