- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03079843
Particulate Matter, Blood Pressure, and the Sympathetic Nervous System (PM-SNS)
30 de abril de 2019 actualizado por: Robert Brook, University of Michigan
Particulate Matter, Blood Pressure, and the Sympathetic Nervous System: Impact of Near-roadway Exposures and N-95 Facemasks
Healthy volunteers will be exposed to ambient air near a roadway under the conditions of with and without a facemask and their responses will be evaluated.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The investigators will enroll 50 healthy nonsmoking adults (20-65 years old) into a protocol involving 2 separate 5 day long "study blocks".
Each block will consist of 5 separate 2 hour-long "exposure periods" conducted 5 days in a row (Monday - Friday; start: 8 am to end: 10 am) (Table 2: Study flow chart).
Investigators will enroll 2 patients to undergo the trial study blocks simultaneously (one subject starting block 1 in the active intervention by wearing the facemask and the other wearing no facemask to begin block 1).
Day 1 (Monday) of each study block will occur in a non-polluted clean indoor setting (Research Exam Room, Suite A 1310; Lobby A, Dominos Farms).
All subsequent exposure periods (days 2-5, Tuesday through Friday) of each study block will all take place at the same designated "exposure site", an Ann Arbor Transportation Association (AATA) parking lot area nearby several busy roadways in Ann Arbor MI.
To complete the entire study, each subject will perform 2 separate study blocks.
Minimal total study duration is 2 weeks (washout period = 2 days over weekend) to a maximal period of 6 weeks (wash out period = 5 weeks).
During one block, subjects will wear an N-95 respirator facemask (active intervention) during all exposure periods (days 1-5, even during day 1 indoor exposures).
Subjects will remove the mask at the end of the study day after all testing is completed.
Active versus control intervention ordering will be performed in a randomized single-blind cross-over order.
During the other block subjects will wear no facemask (control) during exposure periods.
While subjects will necessarily be aware of the intervention type, the study investigators responsible for evaluating the results will be blinded to the intervention type during all data analyses (i.e., single blind trial).
Throughout all exposure periods, subjects will wear ambulatory BP monitors (ABPM) and ECG Holter monitors to determine brachial BP/aortic hemodynamics measured every 10 minutes and heart rate variability (HRV) metrics measured continuously and averaged into 10 minute epochs corresponding to same time periods as the BP levels, respectively.
Air pollution exposures (PM2.5, black carbon (BC), and ultrafine particle (UFP) count), ambient temperature levels, and noise intensity will be measured continuously at the near-roadway exposure site during all exposure periods (Days 2-5).
All environmental exposure metrics will also be averaged into 10 minute epochs during the exposure periods corresponding to the health outcome times.
Following completion of exposure periods on day 4 (Thursday), subjects will have endothelial function measured by endoPAT (RHI) immediately post-exposures at the near-roadway site, after lying supine resting 5 minutes on a portable support.
Patients will wear facemask throughout RHI testing when in the active intervention block.
On the final day 5 of each study block, all subjects will have blood drawn.
A sub-group (n=20) of subjects (enrolled on a first-come basis) will have SNS activity measured by MSNA.
After blood draws on each study visit day subjects will remove the facemasks and can thereafter carry on with their routine daily activities.
However, subjects will be asked to not deviate from their usual lifestyle during each study block.
Subjects will be specifically directed to not significantly change their lifestyle (e.g., diet, sleep patterns) and/or any routine activity (e.g., exercise regimen, work, commutes, travel) throughout each study block.
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48103
- University of Michigan
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 65 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
2 hours'/ day exposure to particulate matter with no face mask
|
|
Experimental: 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.
Otros nombres:
2 hours'/ day exposure to particulate matter with no face mask
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
blood pressure
Periodo de tiempo: one week
|
increased blood pressure as a result of air pollution exposure without the mask.
|
one week
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Robert Brook, MD, University of Michigan
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de abril de 2017
Finalización primaria (Actual)
30 de abril de 2019
Finalización del estudio (Actual)
30 de abril de 2019
Fechas de registro del estudio
Enviado por primera vez
10 de febrero de 2017
Primero enviado que cumplió con los criterios de control de calidad
8 de marzo de 2017
Publicado por primera vez (Actual)
15 de marzo de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de mayo de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
30 de abril de 2019
Última verificación
1 de abril de 2019
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HUM00122766
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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