N/A
N=80
Physiological Flow of Liquids in Healthy Swallowing
Deglutition · Healthy Swallowing · Aging
Bottom Line
View on ClinicalTrials.gov: NCT04114617 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcome: Primary: Number of Participants With Unsafe Swallowing — 7; 1; 3; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Starch-thickened liquids (Other); Xanthan-gum thickened liquids (Other); Barium concentration (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Health Network, Toronto
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Unsafe Swallowing |
7; 1; 3; 0; 0 | — |
| PRIMARY Amount of Residue in the Pharynx |
0.2; 0.3; 0.6; 0.2; 0.1 | — |
| PRIMARY Number of Participants Displaying More Than 2 Swallows Per Bolus |
6; 2; 2; 3; 3 | — |
| PRIMARY Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow ("Swallow Reaction Time") |
133; 133; 167; 267; 367 | — |
| PRIMARY Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter |
100; 133; 133; 167; 167 | — |
| PRIMARY Duration of Upper Esophageal Sphincter Opening |
467; 467; 467; 400; 400 | — |
| PRIMARY Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway ("Time-to-Laryngeal-Vestibule-Closure") |
133; 133; 133; 167; 133 | — |
| PRIMARY Laryngeal Vestibule Closure Duration |
467; 467; 467; 434; 434 | — |
| PRIMARY Degree of Pharyngeal Constriction |
1; 1.2; 1.2; 0.7; 0.2 | — |
| PRIMARY Diameter of Upper Esophageal Sphincter Opening |
21; 19; 19; 15; 16 | — |
| PRIMARY Pharyngeal Area at Rest |
59 | — |
| SECONDARY Amplitude of Tongue-Palate Pressure |
16.53; 25.51; 28.61; 51.89 | — |
Summary
Thickened liquids are commonly used as an intervention for people with dysphagia (swallowing impairment). However, the field currently lacks a proper understanding of how this intervention works. The overall goal of the project is to collect measurements of bolus flow through the oropharynx (i.e., mouth and throat) during swallowing. The factors that are expected to influence bolus flow include the liquid/food consistency (i.e., thin, slightly-thick, mildly-thick, moderately-thick, extremely thick, solid) and the forces applied during swallowing (i.e., tongue pressures and swallowing muscle contraction). The objective is to determine how these factors interact to influence the flow of a bolus through the oropharynx in healthy swallowing.
Eligibility Criteria
Inclusion Criteria
- healthy adults
Exclusion Criteria
- prior history of swallowing, motor speech, gastro-esophageal or neurological difficulties, chronic sinusitis or taste disturbance
- history of surgery to the speech or swallowing apparatus (other than routine tonsillectomy or adenoidectomy)
- Type 1 Diabetes
- cognitive communication difficulties that may hinder comprehension of the study documents
- known allergies to latex, food coloring or dental glue
- current pregnancy
- recent x-ray to the neck (in the past 6 months)
- occupationally exposure to radiation exceeding 10 milliSieverts in the year
Data sourced from ClinicalTrials.gov (NCT04114617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.