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

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Terminated
Phase 3

Conditions

Pneumonia, Aspiration

Treatments

Behavioral: Thickened liquid administration
Behavioral: Chin-down position

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000362
NIDCD-1159
U01DC003206 (U.S. NIH Grant/Contract)
Protocol 201

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 95 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems