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