|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
15 April 2024 |
|
Main ID: |
NCT03321019 |
|
Date of registration:
|
20/10/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Airway Protective Mechanisms in PD (R01)
|
|
Scientific title:
|
Mechanisms of Airway Protection Dysfunction in Parkinson's Disease |
|
Date of first enrolment:
|
December 12, 2017 |
|
Target sample size:
|
115 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT03321019 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Karen Hegland, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Florida |
| | |
|
Key inclusion & exclusion 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)
Age minimum:
45 Years
Age maximum:
85 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson Disease
|
|
Intervention(s)
|
|
Procedure: Fluoroscopic swallow evaluation
|
|
Other: Event-related evoked potential using electroencephalography (EEG).
|
|
Drug: Capsaicin
|
|
Device: Resistive respiratory loads
|
|
Primary Outcome(s)
|
|
Respiratory sensitivity
[Time Frame: 4 years]
|
|
Urge to cough sensitivity
[Time Frame: 4 years]
|
|
Penetration-aspiration scale
[Time Frame: 4 years]
|
|
Secondary Outcome(s)
|
|
Swallowing timing
[Time Frame: 4 year]
|
|
Cough peak flow rate
[Time Frame: 4 years]
|
|
Secondary ID(s)
|
|
IRB201700959-N
|
|
5R01HD091658-05
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|