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

This study has been terminated.

Sponsored by: National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by: National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier: NCT00000362
  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 III

Genetics Home Reference related topics:   Parkinson disease   

MedlinePlus related topics:   Dementia    Parkinson's Disease    Pneumonia   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

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
Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
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

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

Locations
United States, Wisconsin
University of Wisconsin at Madison & multiple other U.S. locations    
      Madison, Wisconsin, United States

Sponsors and Collaborators

Investigators
Study Chair:     Dr. Joanne Robbins    
Principal Investigator:     Dr. Jeri Logemann    
  More Information

Publications indexed to this study:

Study ID Numbers:   NIDCD-1159, Protocol 201, UO1 DC 03206
First Received:   November 2, 1999
Last Updated:   April 21, 2006
ClinicalTrials.gov Identifier:   NCT00000362
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Deglutition Disorders
Respiratory Tract Infections
Respiratory Tract Diseases
Parkinson Disease
Lung Diseases
Pneumonia, Aspiration
Dementia
Pneumonia

ClinicalTrials.gov processed this record on August 21, 2008




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