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

This study has been terminated.
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:
First received: November 2, 1999
Last updated: April 21, 2006
Last verified: April 2006

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.

Condition Intervention Phase
Pneumonia, Aspiration
Behavioral: Chin-down position
Behavioral: Thickened liquid administration
Phase 3

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

Resource links provided by NLM:

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Estimated Enrollment: 600
Estimated Study Completion Date: January 2006

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000362

United States, Wisconsin
University of Wisconsin at Madison & multiple other U.S. locations
Madison, Wisconsin, United States
Sponsors and Collaborators
Study Chair: Dr. Joanne Robbins
Principal Investigator: Dr. Jeri Logemann
  More Information

No publications provided by National Institute on Deafness and Other Communication Disorders (NIDCD)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000362     History of Changes
Other Study ID Numbers: NIDCD-1159, Protocol 201, UO1 DC 03206
Study First Received: November 2, 1999
Last Updated: April 21, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
Deglutition Disorders
Parkinson Disease
Pneumonia, Aspiration

Additional relevant MeSH terms:
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 20, 2014