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

Primary Purpose

Pneumonia, Aspiration

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Chin-down position
Thickened liquid administration
Sponsored by
National Institute on Deafness and Other Communication Disorders (NIDCD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia, Aspiration focused on measuring Deglutition Disorders, Dementia, Parkinson Disease, Pneumonia, Aspiration

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Wisconsin at Madison & multiple other U.S. locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
April 21, 2006
Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00000362
Brief Title
Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Aspiration
Keywords
Deglutition Disorders, Dementia, Parkinson Disease, Pneumonia, Aspiration

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Chin-down position
Intervention Type
Behavioral
Intervention Name(s)
Thickened liquid administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Joanne Robbins
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dr. Jeri Logemann
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin at Madison & multiple other U.S. locations
City
Madison
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18378947
Citation
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. doi: 10.7326/0003-4819-148-7-200804010-00007. Erratum In: Ann Intern Med. 2008 May 6;148(9):715.
Results Reference
derived

Learn more about this trial

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

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