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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000362
Enrollment
600
Registered
1999-11-03
Start date
Unknown
Completion date
2006-01-31
Last updated
2006-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Aspiration

Keywords

Deglutition Disorders, Dementia, Parkinson Disease, Pneumonia, Aspiration

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.

Interventions

BEHAVIORALChin-down position
BEHAVIORALThickened liquid administration

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 95 Years
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

* 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026