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- Ensaio Clínico 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.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Falso: 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.
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Subjects were exposed to unfiltered air.
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Comparador Ativo: 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.
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Subjects were exposed to low-efficiency filtered air.
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Comparador Ativo: 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.
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Subjects were exposed to high-efficiency filtered air.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
brachial blood pressure
Prazo: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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Brachial blood pressure was measured using a BPTru device.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
noninvasive aortic hemodynamics
Prazo: 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.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
Pulse wave velocity
Prazo: 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.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
|
heart rate variability
Prazo: 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
Prazo: at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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Retinal photography was used to measure retinal arteriole diameters.
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at the same time between 8-10 AM on 3 consecutive days starting 24 hours after filter system placement
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R01NR014484 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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Ensaios clínicos em Air filtration systems without filters (sham)
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