Back to resultsRespiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease
Primary Purpose
Cough, Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Capsaicin
Voluntary cough test
Sponsored by
About this trial
This is an interventional treatment trial for Cough focused on measuring Cough, Reflex, Voluntary, Healthy older adults, Parkinson's disease, Respiratory kinematics, Cueing
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)
Sites / Locations
- Center for Movement Disorders and Neurorestoration
- Dauer Hall, University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy older adults
Parkinson's disease
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02183519
Brief Title
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
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough, Parkinson's Disease
Keywords
Cough, Reflex, Voluntary, Healthy older adults, Parkinson's disease, Respiratory kinematics, Cueing
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Participants with Parkinson's Disease are evaluated in parallel against a control group of health older adults
Masking
None (Open Label)
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.
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy older adults
Arm Type
Experimental
Arm 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.
Arm Title
Parkinson's disease
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Voluntary cough test
Intervention Description
Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.
Primary Outcome Measure Information:
Title
Peak Expiratory Flow Rate
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen W. Hegland, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexandra E. Brandimore, M.A. CCC/SLP
Organizational Affiliation
University of Florida
Official's Role
Study Director
Facility Information:
Facility Name
Center for Movement Disorders and Neurorestoration
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Dauer Hall, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22144580
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.
Results Reference
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Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease
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