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

Stopped early · Phase 3

Conditions studied: Pneumonia, Aspiration

In brief

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.

Key facts

Study ID: NCT00000362
Run by: National Institute on Deafness and Other Communication Disorders (NIDCD)
People needed: 600
Expected to finish: 2006-01-01
Last updated by the study team: 2006-04-24

Who can join

Age: 50 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have dementia or Parkinson's disease and are found to aspirate on thin liquid during a set of qualifying swallows.

You may not qualify if…

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.

Where it is running

University of Wisconsin at Madison & multiple other U.S. locations — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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