Cough According to Stimulus Type in PD
Airway Protection Deficits According to Stimulus Type in Parkinson's Disease
2 other identifiers
interventional
158
1 country
1
Brief Summary
Aspiration pneumonia (APn) occurs at a higher rate in patients with Parkinson's disease (PD) versus healthy adults. This is of particular public health concern given that death secondary to aspiration pneumonia and lung infection is a leading cause of death in persons with PD. Swallowing and cough function are affected in PD, putting people with PD at significant risk for uncompensated aspiration (aspiration without adequate cough response). One challenge in the management of airway protective deficits related to PD is the chronic and progressive nature of the disease, where swallowing dysfunction appears subtly in the form of microaspiration, reducing the perceived urgency of the swallowing disorder by both clinicians and patients. The long-term goal of this research is to advance the management of airway protection deficits in patients with neurodegenerative disease in order to decrease morbidity and mortality due to aspiration related lung infection. The objective here is to further specify deficits leading to uncompensated airway compromise in PD in order to advance the clinical management of these patients, leading to an immediate positive impact.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2015
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2015
CompletedFirst Posted
Study publicly available on registry
March 17, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2019
CompletedFebruary 15, 2019
February 1, 2019
1.9 years
February 19, 2015
February 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Urge-to-cough sensitivity
Slope of the line created by plotting urge-to-cough (scale of 1-11) with capsaicin concentration (5 doses of increasing intensity).
30 minute
Positive/negative cough response
A positive response is 2 coughs produced to 2/3 trials of the stimulus
10 minutes
Secondary Outcomes (3)
Latency
10 minutes
Cough sensitivity threshold
30 minutes
Cough motor threshold
30 minutes
Other Outcomes (1)
Swallowing group
20 minutes
Study Arms (3)
Healthy control
ACTIVE COMPARATORHealthy age-matched adult participants with no history of Parkinson's disease Participants in this group will receive capsaicin vapor cough provocation test. The vapor will be delivered using a small hand-held nebulizer.
Parkinson's disease - no PA
EXPERIMENTALPeople with Parkinson's disease without penetration or aspiration during swallowing; based on results of videofluoroscopic swallow evaluation. Participants in this group will receive capsaicin vapor and fog cough provocation test using a small, hand-held nebulizer.Participants in the group will also receive a fluoroscopic swallow evaluation.
Parkinson's disease - PA
EXPERIMENTALPeople with Parkinson's disease with penetration or aspiration during swallowing;based on results of videofluoroscopic swallow evaluation.Participants in this group will receive capsaicin vapor and fog cough provocation test using a small, hand-held nebulizer. Participants in the group will also receive a fluoroscopic swallow evaluation.
Interventions
Single-breath and continuous inhalation paradigm to induce cough.
Continuous inhalation of fog until a cough is produced, or up to 60 seconds (whichever is shortest)
Fluoroscopic evaluation of oropharyngeal swallowing function.
A hand-held nebulizer will be used to aerosolize the capsaicin and water solutions. Participants will inhale through the device's mouthpiece, and cough if they need to.
Eligibility Criteria
You may qualify if:
- Within age limits
- For PD group: confirmed diagnosis of idiopathic parkinson's disease
You may not qualify if:
- Uncontrolled hypertension
- Difficulty complying due to neuropsychological dysfunction (i.e., severe depression)
- Allergy to capsaicin or hot peppers
- History of head or neck cancer
- Neurological disorders other than PD (i.e., stroke, etc.)
- \. control participants only: any history of neurologic disorders including PD
- History of smoking in the last 5 years
- Breathing disorders or diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen W Hegland, PHD
University of Florida
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2015
First Posted
March 17, 2015
Study Start
April 1, 2015
Primary Completion
February 10, 2017
Study Completion
February 13, 2019
Last Updated
February 15, 2019
Record last verified: 2019-02