Parkinson DiseaseNCT03321019
Airway Protective Mechanisms in PD (R01)
An observational study of Parkinson Disease, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Capsaicin, Resistive respiratory loads and Event-related evoked potential using electroencephalography (EEG).
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 29 Sep 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32611
About this study
Official title: Mechanisms of Airway Protection Dysfunction in Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Capsaicin, Resistive respiratory loads, Event-related evoked potential using electroencephalography (EEG)., Fluoroscopic swallow evaluation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapsaicinDrug
Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.
Resistive respiratory loadsDevice
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
Also called ERP, RREP
The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
Fluoroscopic swallow evaluationProcedure or surgery
Also called Modified barium swallow
Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Capsaicin; Device: Resistive respiratory loads; Other: Event-related evoked potential using electroencephalography (EEG).; Procedure: Fluoroscopic swallow evaluation | |
| 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. Receives: Drug: Capsaicin; Device: Resistive respiratory loads; Other: Event-related evoked potential using electroencephalography (EEG).; Procedure: Fluoroscopic swallow evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
Secondary outcomes (2)
Cough Peak Flow Rate
Highest airflow rate (in liters per second; L/s) during cough
Measured: 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.
Measured: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start12 Dec 2017
- Primary completion29 Jul 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Karen Hegland, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321019
- Sponsor's protocol ID
- IRB201700959-N
- Other IDs
- 5R01HD091658-05
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2017
- Last updated
- 10 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Airway Protection Dysfunction in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03321019
- Acronym / sponsor ID
- IRB201700959-N
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 29 Jul 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 10 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Drug: Capsaicin, Device: Resistive respiratory loads, Other: Event-related evoked potential using electroencephalography (EEG)., Procedure: Fluoroscopic swallow evaluationMen 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 | – | Drug: Capsaicin, Device: Resistive respiratory loads, Other: Event-related evoked potential using electroencephalography (EEG)., Procedure: Fluoroscopic swallow evaluationMen 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapsaicinParticipants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough. | Drug | Healthy controls, Parkinson's disease |
| Resistive respiratory loadsParticipants 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. | Device | Healthy controls, Parkinson's disease |
| Event-related evoked potential using electroencephalography (EEG).Also: ERP, RREPThe study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation. | Other | Healthy controls, Parkinson's disease |
| Fluoroscopic swallow evaluationAlso: Modified barium swallowParticipants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency. | Procedure or surgery | Healthy controls, Parkinson's disease |
Primary outcome
Respiratory Sensitivity
Time frame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
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.
Urge to Cough Sensitivity
Time frame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
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.
Penetration-aspiration Scale
Time frame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
Rating of airway intrusion of bolus material during swallowing ranging from 1 (best, no airway invasion) to 8 (worst, silent aspiration).
2 secondary outcomes
Cough Peak Flow Rate
Time frame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
Swallowing Timing
Time frame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Hegland, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Sensitivity (time frame: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.