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

Pneumonia, Aspiration Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00000362
• Other study ID #: NIDCD-1159
• Secondary ID: Protocol 201UO1
• Status: Terminated
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: April 21, 2006
• Est. completion date: January 2006

Study information

• Verified date: April 2006
• Source: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Aspiration

Intervention

Behavioral:
• Chin-down position

• Thickened liquid administration

Locations

Country	Name	City	State
United States	University of Wisconsin at Madison & multiple other U.S. locations	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States,