Trial Outcomes & Findings for Airway Protective Mechanisms in PD (R01) (NCT NCT03321019)
NCT ID: NCT03321019
Last Updated: 2024-10-10
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
119 participants
Primary outcome timeframe
3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)
Results posted on
2024-10-10
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
100
|
|
Overall Study
COMPLETED
|
19
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
28
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
22
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Controls
n=19 Participants
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.
|
Parkinson's Disease
n=100 Participants
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.
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=119 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=19 Participants
|
29 Participants
n=100 Participants
|
35 Participants
n=119 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=19 Participants
|
71 Participants
n=100 Participants
|
84 Participants
n=119 Participants
|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 8.5 • n=19 Participants
|
69.1 years
STANDARD_DEVIATION 7.3 • n=100 Participants
|
68.8 years
STANDARD_DEVIATION 7.4 • n=119 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=19 Participants
|
27 Participants
n=100 Participants
|
39 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=19 Participants
|
73 Participants
n=100 Participants
|
80 Participants
n=119 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 participants
n=19 Participants
|
100 participants
n=100 Participants
|
119 participants
n=119 Participants
|
|
Hoehn &Yahr score (PD only)
|
—
|
2 units on a scale
n=100 Participants • Because the Hoehn \& Yahr scale score is a disease-specific measure, it was not completed on the healthy control participants.
|
2 units on a scale
n=100 Participants • Because the Hoehn \& Yahr scale score is a disease-specific measure, it was not completed on the healthy control participants.
|
|
Disease duration (PD only)
1 - 5 years
|
—
|
49 participants
n=100 Participants • Disease duration is specific to Parkinson's participants and not reported for healthy control participants, as there is no disease present.
|
49 participants
n=100 Participants • Disease duration is specific to Parkinson's participants and not reported for healthy control participants, as there is no disease present.
|
|
Disease duration (PD only)
6 - 10 years
|
—
|
26 participants
n=100 Participants • Disease duration is specific to Parkinson's participants and not reported for healthy control participants, as there is no disease present.
|
26 participants
n=100 Participants • Disease duration is specific to Parkinson's participants and not reported for healthy control participants, as there is no disease present.
|
|
Disease duration (PD only)
11 + years
|
—
|
25 participants
n=100 Participants • Disease duration is specific to Parkinson's participants and not reported for healthy control participants, as there is no disease present.
|
25 participants
n=100 Participants • Disease duration is specific to Parkinson's participants and not reported for healthy control participants, as there is no disease present.
|
PRIMARY outcome
Timeframe: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)Population: 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.
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.
Outcome measures
| Measure |
Healthy Controls
n=19 Participants
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.
|
Parkinson's Disease
n=100 Participants
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.
|
|---|---|---|
|
Respiratory Sensitivity
Year 1 visit
|
0.22 scores on a scale / CmH2O
Standard Deviation 0.08
|
0.22 scores on a scale / CmH2O
Standard Deviation 0.07
|
|
Respiratory Sensitivity
Year 2 visit (PD only)
|
—
|
0.21 scores on a scale / CmH2O
Standard Deviation 0.07
|
|
Respiratory Sensitivity
Year 3 visit (PD only)
|
—
|
0.22 scores on a scale / CmH2O
Standard Deviation 0.06
|
PRIMARY outcome
Timeframe: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)Population: 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.
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.
Outcome measures
| Measure |
Healthy Controls
n=19 Participants
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.
|
Parkinson's Disease
n=100 Participants
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.
|
|---|---|---|
|
Urge to Cough Sensitivity
Year 1
|
0.31 scores on a scale / micromolar capsaicin
Standard Deviation 0.08
|
0.22 scores on a scale / micromolar capsaicin
Standard Deviation 0.08
|
|
Urge to Cough Sensitivity
Year 2 (PD only)
|
—
|
0.21 scores on a scale / micromolar capsaicin
Standard Deviation 0.09
|
|
Urge to Cough Sensitivity
Year 3 (PD only)
|
—
|
0.20 scores on a scale / micromolar capsaicin
Standard Deviation 0.09
|
PRIMARY outcome
Timeframe: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)Population: 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).
Rating of airway intrusion of bolus material during swallowing ranging from 1 (best, no airway invasion) to 8 (worst, silent aspiration).
Outcome measures
| Measure |
Healthy Controls
n=19 Participants
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.
|
Parkinson's Disease
n=100 Participants
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.
|
|---|---|---|
|
Penetration-aspiration Scale
Year 1
|
1 score on a scale
Interval 1.0 to 8.0
|
2 score on a scale
Interval 1.0 to 8.0
|
|
Penetration-aspiration Scale
Year 2 (PD only)
|
—
|
2 score on a scale
Interval 1.0 to 8.0
|
|
Penetration-aspiration Scale
Year 3 (PD only)
|
—
|
2 score on a scale
Interval 1.0 to 8.0
|
SECONDARY outcome
Timeframe: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)Population: 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.
Highest airflow rate (in liters per second; L/s) during cough
Outcome measures
| Measure |
Healthy Controls
n=19 Participants
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.
|
Parkinson's Disease
n=100 Participants
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.
|
|---|---|---|
|
Cough Peak Flow Rate
Year 1
|
3.17 Liters of air per second (L/s)
Standard Deviation 1.31
|
3.67 Liters of air per second (L/s)
Standard Deviation 1.31
|
|
Cough Peak Flow Rate
Year 2 (PD only)
|
—
|
3.27 Liters of air per second (L/s)
Standard Deviation 1.2
|
|
Cough Peak Flow Rate
Year 3 (PD only)
|
—
|
3.01 Liters of air per second (L/s)
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: 3 years, three time points (assessed at year 1 visit, year 2 visit, and year 3 visit)Population: 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.
Duration from bolus head passing mandible to laryngeal vestibule closure measured in frames. Data are collected at 33 frames per second.
Outcome measures
| Measure |
Healthy Controls
n=19 Participants
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.
|
Parkinson's Disease
n=100 Participants
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.
|
|---|---|---|
|
Swallowing Timing
Year 1
|
6.10 Frames
Standard Deviation 7.24
|
6.70 Frames
Standard Deviation 10.22
|
|
Swallowing Timing
Year 2 (PD only)
|
—
|
8.85 Frames
Standard Deviation 6.63
|
|
Swallowing Timing
Year 3 (PD only)
|
—
|
8.14 Frames
Standard Deviation 5.32
|
Adverse Events
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parkinson's Disease
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place