NCT03334565

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

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

October 21, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

November 3, 2017

Last Update Submit

October 20, 2020

Conditions

Cardiovascular Diseases in Old Age

Outcome Measures

Primary Outcomes (1)

  • brachial blood pressure

    Brachial blood pressure was measured using a BPTru device.

    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

    at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement

  • Pulse wave velocity

    at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement

  • heart rate variability

    at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement

  • microvasculature tone

    at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement

Study Arms (3)

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.

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.

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.

Device: High efficiency air filtration systems

Interventions

Low efficiency air filtration systemsDEVICE

Subjects were exposed to low-efficiency filtered air.

Low efficiency
High efficiency air filtration systemsDEVICE

Subjects were exposed to high-efficiency filtered air.

High efficiency
Air filtration systems without filters (sham)DEVICE

Subjects were exposed to unfiltered air.

Sham

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 85 years old
  • non-smoking healthy adults

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30208394DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 3, 2017

First Posted

November 7, 2017

Study Start

October 21, 2014

Primary Completion

November 4, 2016

Study Completion

November 4, 2016

Last Updated

October 22, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share