Clinical trial NCT03321019: Airway Protective Mechanisms in PD (R01)
Official title: Mechanisms of Airway Protection Dysfunction in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-10-25
Enrollment: 119
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes both male and female participants. One study group (control group) will be adults between 45 and 85 years of age without Parkinson's disease. The other group will consist of adults between 45 and 85 years of age with Parkinson's disease diagnosed by a movement disorders trained neurologist, according to UK brain bank criteria.

Brief summary: This study will collect data on various aspects of airway sensation and function, and determine how it relates to the development of swallowing and cough dysfunction in Parkinson's disease. Participants will be followed over a 3-year period, with once-per-year visits to collect the data.

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.

Eligibility criteria: Inclusion Criteria:

1. Between the ages of 45 and 85 years
2. 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:

1. Neurological disorders other than PD (i.e., stroke, etc.)
2. Difficulty complying due to neuropsychological dysfunction (i.e., severe depression)
3. Allergy to capsaicin or hot peppers
4. History of head or neck cancer
5. History of smoking in the past 5 years
6. Any neurological disorder including PD (Healthy control group only)

Primary outcomes:
measure: Respiratory Sensitivity
timeFrame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
measure: Urge to Cough Sensitivity
timeFrame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
measure: Penetration-aspiration Scale
timeFrame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
Secondary outcomes:
measure: Cough Peak Flow Rate
timeFrame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
measure: Swallowing Timing
timeFrame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Center for Movement Disorders and Neurorestoration
state: Florida
Study officials:
affiliation: University of Florida
name: Karen Hegland, PhD
role: PRINCIPAL_INVESTIGATOR
References: