- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03321019
Airway Protective Mechanisms in PD (R01)
Mechanisms of Airway Protection Dysfunction in Parkinson's Disease
Study Overview
Status
Conditions
Detailed Description
Aspiration pneumonia (APn) occurs at a disproportionately hig rate in patients with Parkinson's disease (PD) versus healthy age-matched older adults. This is of particular public health concern given that aspiration pneumonia infection is a leading cause of death in persons with PD. The development of APn is multifactorial with aspiration of material from disordered swallowing (dysphagia) without proper cough response being the main contributing factor. These findings reflect the fact that both swallowing and cough are sensorimotor behaviors, and thus require appropriate detection and scaling of a sensory stimulus in order to produce an appropriate motor response.
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, which is a critical step in pursuit of that goal, is to further specify the sensory mechanisms associated with airway protection disorders in order to advance the clinical management of these patients. In order to accomplish the objective of this application the study team has identified 3 aims: First, determine relationship(s) between airway somatosensation, reflex cough and swallowing function in people with PD, and how these relationships may change with disease progression, over time. Second, determine whether cortical processing of sensory information is associated with deficits in reflex cough sensitivity or swallowing function in people with PD, and third, to determine how the central neural filtering of airway sensory stimuli may relate to the development of airway protective disorders.
The study team will accomplish these aims in 2 experimental studies. First, the study team will test the magnitude of respiratory resistive loads, in people with PD across a range of disease durations, and in a healthy control group. The study team will measure reflex cough, using a cough-inducing irritant (capsaicin), and swallowing function. The study team will perform these tests at 3 time-points, spaced 10-14 months apart, in order to determine the relationships between respiratory sensation, cough sensitivity and effectiveness, and swallowing function, and how they change with advancing disease duration.
Next the study team will perform electroencephalographic recordings time-locked to paired respiratory stimuli to determine cortical processing of airway sensory information. The study team will measure the amplitude and latency of the sensory evoked potential peaks, and compute ratios of peak amplitude between the first and second paired stimulus in order to determine the degree of sensory gating. The realization of the proposed aims and studies is significant because it is a necessary step in our program of research that is expected to lead to earlier, more accurate identification, as well as targeted interventions for airway protection deficits in PD.
Completion of this research is systematically important for our goal of maintaining adequate airway protective function in PD patients; the results are expected to directly impact reductions in health care costs, morbidity, and mortality related to airway protection deficits.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Karen Hegland, PhD
- Phone Number: 352 294 8366
- Email: kwheeler@ufl.edu
Study Locations
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Florida
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Gainesville, Florida, United States, 32611
- University of Florida Center for Movement Disorders and Neurorestoration
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Between the ages of 45 and 85 years
- Diagnosis of PD, Hoehn and Yahr stages I - IV, by a fellowship trained neurologist arriving at the diagnosis of PD by applying strict UK brain bank criteria (PD participants only)
Exclusion Criteria:
- Neurological disorders other than PD (i.e., stroke, etc.)
- Difficulty complying due to neuropsychological dysfunction (i.e., severe depression)
- Allergy to capsaicin or hot peppers
- History of head or neck cancer
- History of smoking in the past 5 years
- Any neurological disorder including PD (Healthy control group only)
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy controls
Men and women between the ages of 45 and 85 years without Parkinson's disease, or any history of neurologic disorder/disease, head or neck cancer, or chronic respiratory illness.
|
Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.
Participants will breath through a mouthpiece.
Every 3-5 breaths in, a respiratory load will be applied.
Participants will be asked to rate the magnitude of the load.
The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
Other Names:
Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
Other Names:
|
Parkinson's disease
Men and women between the ages of 45 and 85 years with Parkinson's disease, and without any history of neurologic disorder/disease, head or neck cancer, or chronic respiratory illness.
|
Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.
Participants will breath through a mouthpiece.
Every 3-5 breaths in, a respiratory load will be applied.
Participants will be asked to rate the magnitude of the load.
The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
Other Names:
Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory sensitivity
Time Frame: 4 years
|
Slope of perception of resistive load and load resistance
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4 years
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Urge to cough sensitivity
Time Frame: 4 years
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Slope of urge to cough and capsaicin concentration
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4 years
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Penetration-aspiration scale
Time Frame: 4 years
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Rating of airway intrusion of bolus material during swallowing
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4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough peak flow rate
Time Frame: 4 years
|
Highest airflow rate during cough
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4 years
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Swallowing timing
Time Frame: 4 year
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Duration from bolus head passing mandible to laryngeal vestibule closure
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4 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karen Hegland, PhD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Parkinson Disease
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Sensory System Agents
- Dermatologic Agents
- Antipruritics
- Capsaicin
Other Study ID Numbers
- IRB201700959-N
- 5R01HD091658-05 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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