Particulate Matter, Blood Pressure, and the Sympathetic Nervous System (PM-SNS)
Particulate Matter, Blood Pressure, and the Sympathetic Nervous System: Impact of Near-roadway Exposures and N-95 Facemasks
Studie Overzicht
Toestand
Toestand
Conditie
Conditie
Interventie / Behandeling
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Studietype
Inschrijving (Werkelijk)
Inschrijving
Fase
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Michigan
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Ann Arbor, Michigan, Verenigde Staten, 48103
- University of Michigan
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Deelname Criteria
Geschiktheidscriteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 1. Age 18-65 years old. People older than 65 years are excluded as the impact of PM2.5 on their BP is not known from our prior studies (which included younger individuals) and they have age-related increases in BP and SNS activity which may alter their associations with PM2.5 exposures and thus produce too heterogeneous a population to evaluate the linkages between PM2.5 and health outcomes.
- 2. Self-reported nonsmoker (100% abstinence for at least 1 year) living in non-smoking households (no one living in the household that smokes indoors) and no known routine exposures to air pollutants by known point sources at home, travel or occupationally (e.g., fumes, dust, secondhand smoke). Smoking and other exposures may alter any effect that ambient PM2.5 has on the health outcomes.
- 3. Able to understand the informed consent, legally provide informed consent, and able to participate for the entire duration of the study.
Exclusion Criteria:
- 1. Any facial hair (beard or mustache) that does not allow for proper fitting and air tight seal of the N95 facemask during the study that would compromise the ability of the mask to prevent exposures.
- 2. Any prior cardiovascular diseases (coronary artery disease (CAD), congestive heart failure (CHF), stroke, peripheral arterial disease (PAD), aneurysms, any revascularization)*
- 3. Prior diagnosis of hypertension, diabetes, sleep apnea*
- 4. Prior diagnosis of chronic lung diseases (asthma, chronic obstructive lung disease (COPD))*
- 5. Prior diagnosis of neurological disorders (Parkinson's disease, autonomic failure, peripheral neuropathy, seizure disorder) or other conditions at discretion of investigators*
- 6. Prior diagnosis of chronic kidney disease, any type of dialysis*
- 7. Active or history of any known cancer*
- 8. History of HIV*
- 9. Being treated for any infection with antibiotics within past month*
- 10. Mental health issue(s) including anxiety disorders, mood disorders, schizophrenia, or other conditions at discretion of investigators*
- 11. Prior diagnosis of any other chronic or acute medical condition(s) at discretion of investigators that may lead to alteration of baseline SNS activity, BP, or insulin sensitivity and thereby potentially impact the association of PM2.5 with study outcomes.
- 12. Medications for high BP or that alter BP. Any medications for cholesterol (e.g., statins). Any medications that alter blood glucose (e.g., diabetes medication)*.
- 13. Any medications or over the counter pills that may alter the association between ambient PM2.5 and the health outcomes of BP, SNS activity and insulin sensitivity by discretion of investigators*. No over the counter pills taken on routine basis (>2 times per week as standing dosage) including: anti-oxidants (vitamin C, E), NSAIDS, fish oil supplements, folic acid supplements, multivitamins, or other over the counter pills, herbs, or complimentary therapies under the discretion of the investigators. These pills can be stopped for 3 months on an elective basis and then the individual can enter the study. Other medications for chronic stable conditions that are not listed in exclusion criteria and that are not likely to influence the study results can be taken or continued as long as their doses have been stable for 3 months prior to entering the study. Estrogen or birth control can be used (any type) as long as the dosing has been stable for past 3 months. Medications or over the counter drugs used on an as needed basis (such as Tylenol or aspirin) are fine as long as not routinely taken >2 times per week)* Planned major change in lifestyle including work, activity, exercise, diet, weight during course of study*
- 14. Screening visit BP ≥140/90 mm Hg (as measured by the automated office BP device- BpTru)
- 15. Screening visit arm circumference ≥17 inches (makes home BP monitoring inaccurate as the cuff of the commercially-available devices will not fit).
- 16. Screening visit pregnancy (positive urine pregnancy test in women <50 years of age) and any plan to become pregnant during the study period
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Aantal wapens
Wapens en interventies
Deelnemersgroep / ArmDeelnemersgroep / Arm |
Interventie / BehandelingInterventie / Behandeling |
|---|---|
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Experimenteel: facemask first then no face mask
wearing of mask each day for the two hours of exposure for the first week of exposure then not wearing the mask each day for the two hours of exposure for the second week of exposure
|
2 hours' / day exposure to particulate matter face mask worn during exposure.
Andere namen:
2 hours'/ day exposure to particulate matter with no face mask
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Experimenteel: no face mask followed by wearing face mask
not wearing the mask each day for the two hours of exposure for the first week of exposure then wearing the mask each day for the two hours of exposure for the second week of exposure
|
2 hours' / day exposure to particulate matter face mask worn during exposure.
Andere namen:
2 hours'/ day exposure to particulate matter with no face mask
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
blood pressure
Tijdsspanne: one week
|
increased blood pressure as a result of air pollution exposure without the mask.
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one week
|
Medewerkers en onderzoekers
Sponsor
Sponsor
Onderzoekers
Onderzoekers
- Hoofdonderzoeker: Robert Brook, MD, University of Michigan
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Studie start
Primaire voltooiing (Werkelijk)
Primaire voltooiing
Studie voltooiing (Werkelijk)
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Eerst geplaatst
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update geplaatst
Laatste update ingediend die voldeed aan QC-criteria
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
Andere studie-ID-nummers
- HUM00122766
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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