Expired Study
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Madison, Wisconsin


Purpose:

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.


Criteria:

Inclusion Criteria: - Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows. Exclusion Criteria: - Have smoked more than a pack of cigarettes per day in the last year. - Drink more than 3 alcoholic beverages per day on a regular basis. - Have had any head and neck cancer treatment. - Have any head and neck anatomic deformities. - Have a history of 20 years or longer of insulin-dependent diabetes. - Have other exclusionary neurologic diagnoses. - Have had pneumonia within 6 weeks of screening. - Currently have a nasogastric tube. - Currently have a tracheotomy. - Are a resident in non-participating nursing home or assisted living environment. - Live alone. - Have no regular care provider present at meals. - Have no Speech-Language Pathologist to provide a 3-month follow-up.


NCT ID:

NCT00000362


Primary Contact:

Study Chair
Dr. Joanne Robbins


Backup Contact:

N/A


Location Contact:

Madison, Wisconsin
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 19, 2017

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