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

This study has been terminated.
Sponsor:
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:
NCT00000362
First received: November 2, 1999
Last updated: April 21, 2006
Last verified: April 2006

November 2, 1999
April 21, 2006
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Complete list of historical versions of study NCT00000362 on ClinicalTrials.gov Archive Site
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Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
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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.

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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Pneumonia, Aspiration
  • Behavioral: Chin-down position
  • Behavioral: Thickened liquid administration
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Robbins J, Gensler G, Hind J, Logemann JA, Lindblad AS, Brandt D, Baum H, Lilienfeld D, Kosek S, Lundy D, Dikeman K, Kazandjian M, Gramigna GD, McGarvey-Toler S, Miller Gardner PJ. Comparison of 2 interventions for liquid aspiration on pneumonia incidence: a randomized trial. Ann Intern Med. 2008 Apr 1;148(7):509-18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
600
January 2006
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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.
Both
50 Years to 95 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000362
NIDCD-1159, Protocol 201, UO1 DC 03206
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National Institute on Deafness and Other Communication Disorders (NIDCD)
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Study Chair: Dr. Joanne Robbins
Principal Investigator: Dr. Jeri Logemann
National Institute on Deafness and Other Communication Disorders (NIDCD)
April 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP