N/A
Completed N=119
Airway Protective Mechanisms in PD (R01)
Source: ClinicalTrials.gov NCT03321019 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Respiratory Sensitivity — 0.22; 0.22; 0.21; 0.22 scores on a scale / CmH2O — p=<.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Sensitivity |
0.22; 0.22; 0.21; 0.22 | <.0001 sig |
| PRIMARY Urge to Cough Sensitivity |
0.31; 0.22; 0.21; 0.20 | 0.72 |
| PRIMARY Penetration-aspiration Scale |
1; 2; 2; 2 | 0.02 sig |
| SECONDARY Cough Peak Flow Rate |
3.17; 3.67; 3.27; 3.01 | 0.034 sig |
| SECONDARY Swallowing Timing |
6.10; 6.70; 8.85; 8.14 | 0.022 sig |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT03321019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.