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Trial NCT00000362

Resource URI: http://static.linkedct.org/resource/trials/NCT00000362
PropertyValue
linkedct:brief_title Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
linkedct:condition <http://static.linkedct.org/resource/condition/10218>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 95 Years
linkedct:eligibility_minimum_age 50 Years
linkedct:end_date January 2006
linkedct:enrollment 600 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000362
rdfs:label Trial NCT00000362
linkedct:lastchanged_date April 21, 2006
linkedct:lead_sponsor_agency National Institute on Deafness and Other Communication Disorders (NIDCD)
linkedct:location <http://static.linkedct.org/resource/location/146590>
linkedct:nct_id NCT00000362
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NIDCD-1159
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/14961>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/14963>
linkedct:overall_status Terminated
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000362>
linkedct:phase Phase 3
linkedct:secondary_id Protocol 201
linkedct:secondary_id UO1 DC 03206
linkedct:source National Institute on Deafness and Other Communication Disorders (NIDCD)
linkedct:study_design Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date April 2006