Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
Eligibility| 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| United States, Wisconsin | |
| University of Wisconsin at Madison & multiple other U.S. locations | |
| Madison, Wisconsin, United States | |
| 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 Dementia Parkinson Disease Pneumonia, Aspiration |
Additional relevant MeSH terms:
|
Pneumonia Pneumonia, Aspiration Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on June 18, 2013