Clinical Trials Directory

Trials / Completed

CompletedNCT04114617

Physiological Flow of Liquids in Healthy Swallowing

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
University Health Network, Toronto · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Detailed description

The aims of this study are as follows: Aim 1: To determine the relationship between bolus flow and healthy swallowing physiology. The investigators will collect concurrent videofluoroscopic and physiological measures of swallowing (tongue pressure, electromyography \[sEMG\]) in healthy adults using barium stimuli across the continuum of liquid consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquids, as defined by the International Dysphagia Diet Standardisation Initiative, www.iddsi.org). Significance: This will show the impact of consistency on bolus flow through the oropharynx, controlling for the forces used to initiate flow and propel the bolus. Aim 2: To compare healthy swallowing physiology for barium versus non-barium stimuli. The investigators will collect physiological measures of swallowing using barium and non-barium stimuli matched for consistency. Significance: This will determine how swallowing behaviors (tongue pressures, sEMG) differ between barium and non-barium stimuli with matched consistency, enabling us to develop models of flow accounting for these differences. Aim 3: To compare healthy swallowing physiology across different commercial barium products. Significance: This will determine whether differences in barium concentration or brand influence swallowing behaviors, enabling us to make recommendations regarding ideal contrast agents for use in radiographic swallowing assessment.

Conditions

Interventions

TypeNameDescription
OTHERStarch-thickened liquidsThickener added in amounts required to reach slightly thick, mildly thick, moderately thick and extremely thick consistencies, as defined by the International Dysphagia Diet Standardisation Initiative flow test.
OTHERXanthan-gum thickened liquidsThickener added in amounts required to reach slightly thick, mildly thick, moderately thick and extremely thick consistencies, as defined by the International Dysphagia Diet Standardisation Initiative flow test.
COMBINATION_PRODUCTBarium concentrationCommercially available barium products diluted to different concentrations (i.e., 20% w/v, 40% w/v) through the addition of water

Timeline

Start date
2016-01-01
Primary completion
2019-09-12
Completion
2020-12-31
First posted
2019-10-03
Last updated
2022-12-21
Results posted
2022-12-21

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04114617. Inclusion in this directory is not an endorsement.