Clinical trial NCT00000362: Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pneumonia, Aspiration
Keywords: Deglutition Disorders
Dementia
Parkinson Disease
Pneumonia, Aspiration
Lead sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)
Sponsor class: NIH
First posted: 1999-11-03
Enrollment: 600
Sex: ALL
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin at Madison & multiple other U.S. locations
state: Wisconsin
Study officials:
name: Dr. Joanne Robbins
role: STUDY_CHAIR
name: Dr. Jeri Logemann
role: PRINCIPAL_INVESTIGATOR
References:
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.