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

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

This study has been terminated.

Study NCT00000362. Last updated on April 21, 2006. Information provided by National Institute on Deafness and Other Communication Disorders (NIDCD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Pneumonia, Aspiration

Intervention ^†

Behavioral: Chin-down position
Behavioral: Thickened liquid administration

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

600

Start Date ^†

Completion Date

January 2006

Eligibility 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.

Gender

Both

Ages

50 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00000362

Organization ID

NIDCD-1159

Secondary IDs ^††

Protocol 201, UO1 DC 03206

Study Sponsor ^†

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborators ^††

Investigators ^†

Study Chair:	Dr. Joanne Robbins
Principal Investigator:	Dr. Jeri Logemann

Information Provided By

National Institute on Deafness and Other Communication Disorders (NIDCD)

Verification Date

April 2006

First Received Date ^†

November 2, 1999

Last Updated Date

April 21, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.