Clinical trial NCT02183519: Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease
Official title: Respiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cough
Parkinson's Disease
Keywords: Cough
Reflex
Voluntary
Healthy older adults
Parkinson's disease
Respiratory kinematics
Cueing
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 44
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with Parkinson's Disease are evaluated in parallel against a control group of health older adults
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Peak Expiratory Flow Rate
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Center for Movement Disorders and Neurorestoration
state: Florida
city: Gainesville
country: United States
facility: Dauer Hall, University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Karen W. Hegland, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Alexandra E. Brandimore, M.A. CCC/SLP
role: STUDY_DIRECTOR
References:
citation: 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.