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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HD091658-05 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Drug | Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Sensitivity | Slope of perception of resistive load and load resistance: Magnitude estimation of respiratory load (6 - no difficulty inhaling - 20 maximum difficulty inhaling) is plotted on the y-axis and respiratory load (0, 5, 10, 25 & 40 cm H2O loads) is plotted on the x-axis. The slope of the resulting regression line is the measure. | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
| Urge to Cough Sensitivity | Urge to cough sensitivity slope: Slope of the line created by plotting the urge to cough (0 indicating none - 10 indicating maximal) on the y-axis and capsaicin concentration (increasing from 0, 25, 50, 100, 200 micromolar) on the x-axis. | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
| Penetration-aspiration Scale | Rating of airway intrusion of bolus material during swallowing ranging from 1 (best, no airway invasion) to 8 (worst, silent aspiration). | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Cough Peak Flow Rate | Highest airflow rate (in liters per second; L/s) during cough | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
| Swallowing Timing | Duration from bolus head passing mandible to laryngeal vestibule closure measured in frames. Data are collected at 33 frames per second. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Karen Hegland, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Center for Movement Disorders and Neurorestoration | Gainesville | Florida | 32611 | United States |
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Participant recruitment began 12/2017 and ended 2/2022. Participants with Parkinson Disease (PD) were recruited from an IRB-approved clinical database of people with PD. Healthy (non-PD) participants were recruited using advertisement fliers and word-of-mouth. All participants were seen in research space at the outpatient Fixel Institute for Neurological Diseases at the University of Florida.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Capsaicin: Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. 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. 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. Fluoroscopic swallow evaluation: Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. |
| FG001 | 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. Capsaicin: Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. 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. 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. Fluoroscopic swallow evaluation: Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Capsaicin: Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. 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. 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. Fluoroscopic swallow evaluation: Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Respiratory Sensitivity | Slope of perception of resistive load and load resistance: Magnitude estimation of respiratory load (6 - no difficulty inhaling - 20 maximum difficulty inhaling) is plotted on the y-axis and respiratory load (0, 5, 10, 25 & 40 cm H2O loads) is plotted on the x-axis. The slope of the resulting regression line is the measure. | The healthy control group had only 1 visit, whereas the PD group had 3 visits. Thus, the 2nd and 3rd rows in the outcome measure table are pertinent only to the PD participants. The numbers analyzed for the PD group in years 2 and 3 are smaller than year 1 due to participant withdrawals or loss to follow up. | Posted | Mean | Standard Deviation | scores on a scale / CmH2O | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
|
Adverse even data were collected at year 1 visit, year 2 visit, and year 3 visit for each participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Capsaicin: Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. 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. 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. Fluoroscopic swallow evaluation: Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. |
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This study spanned the time of the global COVID pandemic, so many of the participants lost to follow up, and limited ability to recruit, were a direct result of restrictions put in place between March 2020 and March 2021.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Hegland | University of Florida | 3522948366 | kwheeler@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2020 | Jul 26, 2024 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF2_longitudinal | Oct 30, 2018 | Jul 26, 2024 | ICF_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: longitudinal study | Feb 19, 2020 | Jul 26, 2024 | ICF_006.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| Resistive respiratory loads | Device | 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. |
|
| Event-related evoked potential using electroencephalography (EEG). | Other | The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation. |
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| Fluoroscopic swallow evaluation | Procedure | Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. |
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| 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
| BG001 | 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. Capsaicin: Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. 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. 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. Fluoroscopic swallow evaluation: Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hoehn &Yahr score (PD only) | The Hoehn & Yahr scale is a commonly used system for describing how the symptoms of Parkinson's disease progress. The scale varies from 0: no sign of disease, to stage 5: needing a wheelchair or bedridden unless assisted. | Because the Hoehn & Yahr scale score is a disease-specific measure, it was not completed on the healthy control participants. | Median | Full Range | units on a scale |
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| Disease duration (PD only) | Disease duration is based on years since the diagnosis of Parkinson's disease. The number of participants in each duration range category (1 - 5 years, 6 - 10 years, and 11 or more years) is reported. | Disease duration is specific to Parkinson's participants and not reported for healthy control participants, as there is no disease present. | Number | participants |
|
| OG001 | 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. Capsaicin: Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. 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. 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. Fluoroscopic swallow evaluation: Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. |
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| Primary | Urge to Cough Sensitivity | Urge to cough sensitivity slope: Slope of the line created by plotting the urge to cough (0 indicating none - 10 indicating maximal) on the y-axis and capsaicin concentration (increasing from 0, 25, 50, 100, 200 micromolar) on the x-axis. | For the PD group, the numbers analyzed in years 2 and 3 of the study reflect loss of participants to either withdrawal or loss to follow up. | Posted | Mean | Standard Deviation | scores on a scale / micromolar capsaicin | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
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| Primary | Penetration-aspiration Scale | Rating of airway intrusion of bolus material during swallowing ranging from 1 (best, no airway invasion) to 8 (worst, silent aspiration). | For the PD group, the numbers analyzed in years 2 and 3 of the study reflect loss of participants to either withdrawal or loss to follow up. In some cases fluoroscopy was not available in the year 2 or 3 visit, so some participants were not included due to no data for those visits. Not that on the Penetration-Aspiration scale used, higher numbers are worse, with the full range being 1 (normal swallow) to 8 (silent aspiration). | Posted | Median | Full Range | score on a scale | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
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| Secondary | Cough Peak Flow Rate | Highest airflow rate (in liters per second; L/s) during cough | For the PD group, the numbers analyzed in years 2 and 3 of the study reflect loss of participants to either withdrawal or loss to follow up. The measure (L/s) is airflow - higher is better (indicating more airflow out per second), a measure of cough effectiveness. | Posted | Mean | Standard Deviation | Liters of air per second (L/s) | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
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| Secondary | Swallowing Timing | Duration from bolus head passing mandible to laryngeal vestibule closure measured in frames. Data are collected at 33 frames per second. | For the PD group, the numbers analyzed in years 2 and 3 of the study reflect loss of participants to either withdrawal or loss to follow up. | Posted | Mean | Standard Deviation | Frames | 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit) |
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. Capsaicin: Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. 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. 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. Fluoroscopic swallow evaluation: Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. | 0 | 100 | 0 | 100 | 0 | 100 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| Year 2 (PD only) |
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| Year 3 (PD only) |
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| Year 2 (PD only) |
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| Year 3 (PD only) |
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| Year 2 (PD only) |
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| Year 3 (PD only) |
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| Year 2 (PD only) |
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| Year 3 (PD only) |
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