NCT00000362

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (planned)
• Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD) · NIH
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia, Aspiration

Interventions

Type	Name	Description
BEHAVIORAL	Chin-down position
BEHAVIORAL	Thickened liquid administration

Timeline

• Completion: 2006-01-01
• First posted: 1999-11-03
• Last updated: 2006-04-24

Locations

1 site across 1 country: United States