Cough, Parkinson's Disease
Conditions
Keywords
Cough, Reflex, Voluntary, Healthy older adults, Parkinson's disease, Respiratory kinematics, Cueing
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.
Interventions
DRUGCapsaicin
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.
OTHERVoluntary cough test
Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.
Sponsors
University of Florida
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Participants with Parkinson's Disease are evaluated in parallel against a control group of health older adults
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Expiratory Flow Rate | 1-2 hours | 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. |
Countries
United States
Participant flow
Recruitment details
Parkinson's Disease = PD and Healthy Older Adult = HOA
Pre-assignment details
10 PD participants did not respond to 200micro-molar capsaicin, and received the 500 micro-molar single dose. 3/10 PD participants did not respond to 500, and thus did not produce analyzable data. Due to a computer error, data was lost for 3 of the HOA participants. Complete data sets were analyzed for 13 PD and 25 HOA participants.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 13 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | computer error | 3 | 0 |
| Overall Study | Did not respond to cough inducter | 0 | 3 |
Baseline characteristics
| Characteristic | Healthy Older Adults | Parkinson's Disease | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 11 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 2 Participants | 7 Participants |
| Region of Enrollment United States | 25 participants | 13 participants | 38 participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 14 Participants | 7 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 13 |
| other Total, other adverse events | 0 / 25 | 0 / 13 |
| serious Total, serious adverse events | 0 / 25 | 0 / 13 |
Outcome results
Primary
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.
Time frame: 1-2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Older Adults | Peak Expiratory Flow Rate | 4.34 Liters of air/second | Standard Deviation 0.202 |
| Parkinson's Disease | Peak Expiratory Flow Rate | 3.92 Liters of air/second | Standard Deviation 0.274 |