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Physiological Flow of Liquids in Healthy Swallowing

University Health Network, Toronto logo

University Health Network, Toronto

Status

Completed

Conditions

Aging
Deglutition
Healthy Swallowing

Treatments

Combination Product: Barium concentration
Other: Starch-thickened liquids
Other: Xanthan-gum thickened liquids

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04114617
CAPCR 15-9431 (NIH_HV)
15-9431
5R01DC011020 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Healthy Adults
Description:
Participants will be asked to swallow a series of up to 54 liquid stimuli: a) liquid barium (different brands and concentrations); b) a 20% w/v concentration liquid barium thickened to different consistencies using either a starch-based or xanthan-gum based food thickener; and c) lemon-flavored water thickened to different consistencies using either a starch-based or xanthan-gum based food thickener.
Treatment:
Other: Xanthan-gum thickened liquids
Combination Product: Barium concentration
Other: Starch-thickened liquids

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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