Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease

Respiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's Disease

Patrocinadores

Patrocinador principal: University of Florida

Fuente University of Florida
Resumen breve

The purpose of this research study is to test cough function in individuals with Parkinson's disease and healthy older adults. Cough is a complex, defensive function which involves movement of the chest and lungs. The investigators want to compare the movement of the chest wall and the lungs during voluntary and reflex cough.

The long-term goal of this research is to develop treatments for people with cough dysfunction. Cough dysfunction increases the risk for respiratory infections such as pneumonia. The results from this study will provide information to help researchers understand the difference between reflex and voluntary cough more fully.

Descripción detallada

If the participant agrees to participate, the investigators will first test pulmonary (lung) function. Next, the investigators will test voluntary and reflex cough. After this first round of cough testing, the investigators will ask participants to cough long and hard during voluntary and reflex cough testing. Finally, the investigators will view the larynx (voice box) with an endoscopic camera inserted through the nose. This test is done to see if there are any changes in the larynx that may influence cough.

Estado general Completed
Fecha de inicio October 2014
Fecha de Terminación August 2015
Fecha de finalización primaria August 2015
Fase Phase 1/Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Peak Expiratory Flow Rate 1-2 hours
Inscripción 44
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Capsaicin

Descripción: For reflex cough testing, all participants will receive various concentrations of nebulized capsaicin. Delivery of multiple concentrations and doses of capsaicin allows for accurate assessment of both the strength (airflow measures) of reflex, as well as cough sensitivity.

Tipo de intervención: Other

Nombre de intervención: Voluntary cough test

Descripción: Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.

Elegibilidad

Criterios:

Inclusion Criteria:

- Age 55-85 years

- Ability to provide informed consent

For participants with Parkinson's disease (PD):

- Diagnosis of PD (Hoehn & Yahr stages II-IV) by a University of Florida Movement Disorders fellowship trained neurologist having completed a clinical assessment of each participant's PD severity and arriving at the diagnosis of PD by applying strict United Kingdom brain bank criteria.

Exclusion Criteria:

Participants with PD:

- History of neurological disorders other than PD (e.g. multiple sclerosis, stroke, brain tumor, etc)

Healthy older adults:

- History of neurological disease including PD

- History of head and neck cancer

- History of breathing disorders or disease (i.e. chronic obstructive pulmonary disease, asthma)

- History of smoking for more than 5 years at any one time (as this reduces the sensitivity to capsaicin)

- History of chest infection the last 5 weeks

- Failure of a screening test of pulmonary function (e.g. forced expiratory volume in one second/forced vital capacity<75%)

- Difficulty complying due to neuropsychological dysfunction (i.e. severe depression)

Género: All

Edad mínima: 55 Years

Edad máxima: 85 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Ubicación
Instalaciones:
Center for Movement Disorders and Neurorestoration | Gainesville, Florida, 32611, United States
Dauer Hall, University of Florida | Gainesville, Florida, 32611, United States
Ubicacion Paises

United States

Fecha de verificación

February 2017

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 2
Grupo de brazo

Etiqueta: Healthy older adults

Tipo: Experimental

Descripción: All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

Etiqueta: Parkinson's disease

Tipo: Experimental

Descripción: All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.

Información de diseño del estudio

Asignación: Non-Randomized

Modelo de intervención: Parallel Assignment

Descripción del modelo de intervención: Participants with Parkinson's Disease are evaluated in parallel against a control group of health older adults

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Descripción de enmascaramiento: 1) baseline respiratory maneuvers for calibration of the Respitrace system with spirometry 2) sequential voluntary cough (no cueing), 3) reflex cough sensitivity testing to establish the lowest concentration of capsaicin that elicits a two cough response (C2) (no cueing), 4) randomized production of sequential voluntary cough (3x) or reflex cough induced with C2 (3x) with cueing to 'cough long and hard' and 5) flexible laryngoscopy to assess age-related changes to the larynx that may impact cough function.

Fuente: ClinicalTrials.gov