MedTrace Logo

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

NCT00000362 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2006-04-24

No results posted yet for this study

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

BEHAVIORAL

Chin-down position

BEHAVIORAL

Thickened liquid administration

Sponsors & Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    lead NIH

Principal Investigators

  • Dr. Joanne Robbins

  • Dr. Jeri Logemann

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
2006-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000362 on ClinicalTrials.gov