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NCT03192358 · ClinicalTrials.gov registry record
Physiological Flow of Liquids Used in Dysphagia Management (Neuro)
A clinical trial, sponsored by University Health Network, Toronto.
- Completed
- Registry status
- 40
- Enrollment target
NCT03192358: Completed study, sponsored by University Health Network, Toronto.
NCT03192358 is a clinical trial that has completed, run by University Health Network, Toronto. The registered enrollment target is 40 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03192358 has completed, sponsored by University Health Network, Toronto.
- COMPLETED
- Registry status
- 40 participants
- Enrollment target
Study Summary
For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom. Dysphagia places the affected individual at risk for secondary health consequences, including malnutrition and aspiration pneumonia, and negatively affects quality of life. Thickened liquids are commonly recommended for individuals with dysphagia, as they flow more slowly and reduce the risk of entry into the airway. However, there is limited understanding about how changes in liquid thickness modulate swallowing physiology in individuals with neurodegenerative conditions, and previous reports have shown that increased liquid thickness may contribute to the accumulation of residue in the throat. The purpose of this study is to explore swallowing physiology and function in individuals with neurodegenerative conditions, across five levels of liquid thickness (thin, slightly-thick, mildly-thick, moderately-thick, and extremely-thick), and to identify boundaries of "optimal liquid thickness", which maintain airway safety, without contributing to the accumulation of significant residue. Results from this study will help guide the clinical recommendations for thickened liquids in dysphagia management.
Primary Outcome
Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. Smaller values are conside
Interventions
- DIAGNOSTIC_TEST Videofluoroscopic Swallowing Examination
- OTHER Tongue Strength Measurement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2020-12-31 |
What the finished NCT03192358 record still lists
NCT03192358 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Videofluoroscopic Swallowing Examination is the first listed.
NCT03192358 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03192358 about?
NCT03192358 is a clinical study titled "Physiological Flow of Liquids Used in Dysphagia Management (Neuro)". For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom. Dysphagia places the affected individual at risk for secondary health consequences, including malnutrition and aspi...
What is the current status of trial NCT03192358?
This trial is currently completed. The enrollment target is 40 participants. The study started on 2017-11-01. Estimated completion is 2020-12-31.
What interventions are being tested in trial NCT03192358?
The interventions under investigation include: Videofluoroscopic Swallowing Examination (DIAGNOSTIC_TEST), Tongue Strength Measurement (OTHER).
Who is sponsoring clinical trial NCT03192358?
This trial is sponsored by University Health Network, Toronto, which has 23 total clinical trials registered on ClinicalTrials.gov.
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