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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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16 December 2017 |
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Main ID: |
NCT02183519 |
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Date of registration:
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02/07/2014 |
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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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Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's Disease
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Scientific title:
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Respiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's Disease |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02183519 |
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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: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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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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Alexandra E. Brandimore, M.A. CCC/SLP |
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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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Name:
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Karen W. Hegland, Ph.D. |
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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:
- Age 55-85 years
- Ability to provide informed consent
For participants with Parkinson's disease (PD):
- Diagnosis of PD (Hoehn & Yahr stages II-IV) by a University of Florida Movement Disorders
fellowship trained neurologist having completed a clinical assessment of each participant's
PD severity and arriving at the diagnosis of PD by applying strict United Kingdom brain
bank criteria.
Exclusion Criteria:
Participants with PD:
- History of neurological disorders other than PD (e.g. multiple sclerosis, stroke, brain
tumor, etc)
Healthy older adults:
- History of neurological disease including PD
- History of head and neck cancer
- History of breathing disorders or disease (i.e. chronic obstructive pulmonary disease,
asthma)
- History of smoking for more than 5 years at any one time (as this reduces the
sensitivity to capsaicin)
- History of chest infection the last 5 weeks
- Failure of a screening test of pulmonary function (e.g. forced expiratory volume in
one second/forced vital capacity<75%)
- Difficulty complying due to neuropsychological dysfunction (i.e. severe depression)
Age minimum:
55 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cough
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Parkinson's Disease
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Intervention(s)
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Other: Voluntary cough test
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Drug: Capsaicin
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Primary Outcome(s)
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Peak Expiratory Flow Rate
[Time Frame: 1-2 hours]
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Secondary ID(s)
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IRB201400477
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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