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TerminatedNCT00000362Updated Apr 24, 2006

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

A Phase 3 interventional study of Chin-down position and Thickened liquid administration in Pneumonia, Aspiration, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD). Terminated at 1 site in United States. Open to participants aged 50 Years to 95 Years. Per ClinicalTrials.gov, last updated 2006-04-24.

Sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
50 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumonia, Aspiration

Keywords

  • Deglutition Disorders
  • Dementia
  • Parkinson Disease
  • Pneumonia, Aspiration
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 600 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD) is the lead sponsor of 37 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 95 Years
Sexes eligible
All
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

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.
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
600 participants

Interventions

  • BehavioralChin-down position
  • BehavioralThickened liquid administration
06

Study locations

1 site
  • University of Wisconsin at Madison & multiple other U.S. locations
    Madison, Wisconsin, United States
07

References and documents

Publications

  • 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. PubMed 18378947 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000362
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted
Nov 3, 1999
Completion
Jan 2006
Last update
Apr 24, 2006

Study contacts

Dr. Joanne Robbins
study chair
Dr. Jeri Logemann
principal investigator
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

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