- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03334565
Reducing PM-associated CV Health Effects for Seniors
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.
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.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 50 to 85 years old
- non-smoking healthy adults
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
가짜 비교기: 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.
|
Subjects were exposed to unfiltered air.
|
활성 비교기: Low efficiency
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.
|
Subjects were exposed to low-efficiency filtered air.
|
활성 비교기: High efficiency
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.
|
Subjects were exposed to high-efficiency filtered air.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
brachial blood pressure
기간: 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.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
noninvasive aortic hemodynamics
기간: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Aortic hemodynamics was measured using a SphygmoCor device.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Pulse wave velocity
기간: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Pulse wave velocity was measured using a SphygmoCor device.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
heart rate variability
기간: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Heart rate variability was measured using a SphygmoCor device.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
microvasculature tone
기간: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Retinal photography was used to measure retinal arteriole diameters.
|
at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R01NR014484 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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