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

University of Florida

Status and phase: Completed; Phase 2; Phase 1

Conditions: Parkinson's Disease; Cough

Treatments: Other: Voluntary cough test; Drug: Capsaicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02183519

IRB201400477

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Healthy older adults

Experimental group

Description:

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.

Treatment:

Other: Voluntary cough test

Drug: Capsaicin

Parkinson's disease

Experimental group

Description:

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.

Treatment:

Other: Voluntary cough test

Drug: Capsaicin