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NCT00000362 · ClinicalTrials.gov registry record · Phase 3
Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects
A Phase 3 study, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- Terminated
- Registry status
- Phase 3
- Development phase
- 600
- Enrollment target
NCT00000362 is a Phase 3 study that was terminated before completion, run by National Institute on Deafness and Other Communication Disorders (NIDCD). The registered enrollment target is 600 participants.
The verdict
NCT00000362, a Phase 3 study, was terminated before completion, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 600 participants
- Enrollment target
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.
Interventions
- BEHAVIORAL Chin-down position
- BEHAVIORAL Thickened liquid administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Est. Completion | 2006-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000362
The ClinicalTrials.gov registry entry for NCT00000362 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Chin-down position is the first listed.
NCT00000362 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000362 about?
NCT00000362 is a clinical study titled "Randomized Study of Two Interventions for Liquid Aspiration: Short-Term and Long-Term Effects". 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 popu...
What is the current status of trial NCT00000362?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 600 participants. Estimated completion is 2006-01.
What interventions are being tested in trial NCT00000362?
The interventions under investigation include: Chin-down position (BEHAVIORAL), Thickened liquid administration (BEHAVIORAL).
Who is sponsoring clinical trial NCT00000362?
This trial is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total clinical trials registered on ClinicalTrials.gov.
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