Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects

Study Overview
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Brief Summary
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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.

Conditions
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Pneumonia, Aspiration

Intervention / Treatment
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* Behavioral: Chin-down position
* Behavioral: Thickened liquid administration


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Chin-down position|nan|
|Behavioral: Thickened liquid administration|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deglutition Disorders, Dementia, Parkinson Disease, Pneumonia, Aspiration