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Sponsored by: |
National Institute on Deafness and Other Communication Disorders (NIDCD) |
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Information provided by: | National Institute on Deafness and Other Communication Disorders (NIDCD) |
ClinicalTrials.gov Identifier: | NCT00000362 |
The purpose of this study is to determine whether chin-down posture or use of a thickened liquid diet is more effective in the prevention of aspiration and aspiration pneumonia in patients with Parkinson's disease and/or dementia. Liquid aspiration is the most common type of aspiration in older populations, especially those suffering from debilitation, dementia, and depression. Pneumonia may develop as a consequence of aspiration and is the fifth leading cause of death in the US among persons age 65 years and over. Current treatment involves either use of chin-down position with swallowing or use of thickened liquids in the diet, without any clear evidence supporting the use of one treatment over the other. This is a Phase III inpatient and/or outpatient study in which all participants will be randomly assigned to either the chin-down position or the thickened liquid treatment group based on swallowing function during a modified barium swallow. This study is scheduled to recruit patients for a three-year period; participation by each individual patient spans no more than three months after entry.
Condition | Intervention | Phase |
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Pneumonia, Aspiration |
Behavioral: Chin-down position Behavioral: Thickened liquid administration |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Ages Eligible for Study: | 50 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Wisconsin | |
University of Wisconsin at Madison & multiple other U.S. locations | |
Madison, Wisconsin, United States |
Study Chair: | Dr. Joanne Robbins | |
Principal Investigator: | Dr. Jeri Logemann |
Study ID Numbers: | NIDCD-1159, Protocol 201, UO1 DC 03206 |
Study First Received: | November 2, 1999 |
Last Updated: | April 21, 2006 |
ClinicalTrials.gov Identifier: | NCT00000362 |
Health Authority: | United States: Federal Government |
Deglutition Disorders Dementia Parkinson Disease Pneumonia, Aspiration |
Deglutition Disorders Respiratory Tract Infections Respiratory Tract Diseases Parkinson Disease |
Lung Diseases Pneumonia, Aspiration Dementia Pneumonia |