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| Descriptive Information Fields | |||||||||
| Brief Title † | Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects | ||||||||
| Official Title † | |||||||||
| Brief Summary | 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | |||||||||
| Secondary Outcome Measure † | |||||||||
| Condition † | Pneumonia, Aspiration | ||||||||
| Intervention † | Behavioral: Chin-down position Behavioral: Thickened liquid administration |
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| MEDLINE PMIDs | |||||||||
| Links | |||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Terminated | ||||||||
| Enrollment † | 600 | ||||||||
| Start Date † | |||||||||
| Completion Date | January 2006 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years to 95 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00000362 | ||||||||
| Organization ID | NIDCD-1159 | ||||||||
| Secondary IDs †† | Protocol 201, UO1 DC 03206 | ||||||||
| Study Sponsor † | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Collaborators †† | |||||||||
| Investigators † |
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| Information Provided By | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||||||
| Verification Date | April 2006 | ||||||||
| First Received Date † | November 2, 1999 | ||||||||
| Last Updated Date | April 21, 2006 | ||||||||