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Trial record 3 of 35 for:    Cough | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Airway Protective Mechanisms in PD (R01)

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ClinicalTrials.gov Identifier: NCT03321019
Recruitment Status : Recruiting
First Posted : October 25, 2017
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Florida

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.

Condition or disease Intervention/treatment
Parkinson Disease Drug: Capsaicin Device: Resistive respiratory loads Other: Event-related evoked potential using electroencephalography (EEG). Procedure: Fluoroscopic swallow evaluation

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 : Observational
Estimated Enrollment : 245 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mechanisms of Airway Protection Dysfunction in Parkinson's Disease
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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.
Drug: Capsaicin
Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.

Device: Resistive respiratory loads
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.

Other: Event-related evoked potential using electroencephalography (EEG).
The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
Other Names:
  • ERP
  • RREP

Procedure: Fluoroscopic swallow evaluation
Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
Other Name: Modified barium swallow

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.
Drug: Capsaicin
Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.

Device: Resistive respiratory loads
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.

Other: Event-related evoked potential using electroencephalography (EEG).
The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
Other Names:
  • ERP
  • RREP

Procedure: Fluoroscopic swallow evaluation
Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
Other Name: Modified barium swallow




Primary Outcome Measures :
  1. Respiratory sensitivity [ Time Frame: 4 years ]
    Slope of perception of resistive load and load resistance

  2. Urge to cough sensitivity [ Time Frame: 4 years ]
    Slope of urge to cough and capsaicin concentration

  3. Penetration-aspiration scale [ Time Frame: 4 years ]
    Rating of airway intrusion of bolus material during swallowing


Secondary Outcome Measures :
  1. Cough peak flow rate [ Time Frame: 4 years ]
    Highest airflow rate during cough

  2. Swallowing timing [ Time Frame: 4 year ]
    Duration from bolus head passing mandible to laryngeal vestibule closure



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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321019


Contacts
Contact: Karen Hegland, PhD 352 294 8366 kwheeler@ufl.edu

Locations
United States, Florida
University of Florida Center for Movement Disorders and Neurorestoration Recruiting
Gainesville, Florida, United States, 32611
Contact: Karen W Hegland, PhD    352-273-3711    kwheeler@ufl.edu   
Contact: Yuhan Mou, M.A.       ymou@phhp.ufl.edu   
Sub-Investigator: Paul W Davenport, PhD         
Sub-Investigator: Michael S Okun, MD         
Sponsors and Collaborators
University of Florida
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Karen Hegland, PhD University of Florida
  Study Documents (Full-Text)

Documents provided by University of Florida:

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03321019     History of Changes
Other Study ID Numbers: IRB201700959-N
1R01HD091658-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs