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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000362
First Posted: November 3, 1999
Last Update Posted: April 24, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD)
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000362


Locations
United States, Wisconsin
University of Wisconsin at Madison & multiple other U.S. locations
Madison, Wisconsin, United States
Sponsors and Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
Study Chair: Dr. Joanne Robbins
Principal Investigator: Dr. Jeri Logemann
  More Information

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
U01DC003206 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: April 24, 2006
Last Verified: April 2006

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

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