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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Cough
• Intervention / Treatment: Drug: Capsaicin; Other: Voluntary cough test

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Center for Movement Disorders and Neurorestoration
    • Gainesville, Florida, United States, 32611
      • Dauer Hall, University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy older adults; 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.	Drug: Capsaicin; 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.; Other: Voluntary cough test; Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.
Experimental: Parkinson's disease; 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.	Drug: Capsaicin; 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.; Other: Voluntary cough test; Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Expiratory Flow Rate	Peak expiratory flow rate is the maximum volume of air that is expelled per unit time for each cough in a cough epoch. Measured in liters/second.	1-2 hours

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Karen W. Hegland, Ph.D., University of Florida; Study Director: Alexandra E. Brandimore, M.A. CCC/SLP, University of Florida

Publications and helpful links

General Publications

• Smith JA, Aliverti A, Quaranta M, McGuinness K, Kelsall A, Earis J, Calverley PM. Chest wall dynamics during voluntary and induced cough in healthy volunteers. J Physiol. 2012 Feb 1;590(3):563-74. doi: 10.1113/jphysiol.2011.213157. Epub 2011 Dec 5.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 2, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Cough; Reflex; Parkinson's disease; Healthy older adults; Cueing; Voluntary; Respiratory kinematics
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Respiratory; Parkinson Disease; Cough; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Dermatologic Agents; Antipruritics; Capsaicin
• Other Study ID Numbers: IRB201400477

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No