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Home > "R" Clinical Trials Conditions > Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects  Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
For Condition: Pneumonia, Aspiration
Status: Recruiting
Sponsor(s): National Institute on Deafness and Other Communication Disorders (NIDCD) ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 50 Years/95 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 600
Location and Contact Information:
Overall Study Official:
Dr.Robbins, Study Chair,
University of Wisconsin at Madison & multiple other U.S. locations *Recruiting*
Madison, Wisconsin,
United States
Recruiting
Additional Information:
Study ID Numbers: NIDCD-1159; Protocol 201,UO1 DC 03206
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000362
Other Pneumonia, Aspiration Studies:
1. Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
2. Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
3. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
Related Studies:
Other Pneumonia, Aspiration Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
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