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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02390089 |
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Date of registration:
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19/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Cough According to Stimulus Type in PD
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Scientific title:
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Airway Protection Deficits According to Stimulus Type in Parkinson's Disease |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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158 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02390089 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: Single (Participant).
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Phase:
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Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Karen W Hegland, PHD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Florida |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Within age limits
- For PD group: confirmed diagnosis of idiopathic parkinson's disease
Exclusion Criteria:
- Uncontrolled hypertension
- Difficulty complying due to neuropsychological dysfunction (i.e., severe depression)
- Allergy to capsaicin or hot peppers
- History of head or neck cancer
- Neurological disorders other than PD (i.e., stroke, etc.)
1. control participants only: any history of neurologic disorders including PD
- History of smoking in the last 5 years
- Breathing disorders or diseases
Age minimum:
50 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease
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Intervention(s)
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Other: fog
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Drug: Capsaicin vapor
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Radiation: Videofluoroscopic swallow evaluation
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Device: Nebulizer
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Primary Outcome(s)
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Positive/negative cough response
[Time Frame: 10 minutes]
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Urge-to-cough sensitivity
[Time Frame: 30 minute]
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Secondary Outcome(s)
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Cough motor threshold
[Time Frame: 30 minutes]
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Cough sensitivity threshold
[Time Frame: 30 minutes]
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Latency
[Time Frame: 10 minutes]
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Secondary ID(s)
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IRB201401059-N
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1R21DC014567-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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