Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
80 participants
OBSERVATIONAL
2016-01-01
2020-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Healthy Adults
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.
Starch-thickened liquids
Thickener 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.
Xanthan-gum thickened liquids
Thickener 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.
Barium concentration
Commercially available barium products diluted to different concentrations (i.e., 20% w/v, 40% w/v) through the addition of water
Interventions
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Starch-thickened liquids
Thickener 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.
Xanthan-gum thickened liquids
Thickener 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.
Barium concentration
Commercially available barium products diluted to different concentrations (i.e., 20% w/v, 40% w/v) through the addition of water
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Catriona Steele, PhD
Role: PRINCIPAL_INVESTIGATOR
KITE - Toronto Rehabilitation Institute, University Health Network
Locations
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Toronto Rehabilitation Institute
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CAPCR 15-9431 (NIH_HV)
Identifier Type: OTHER
Identifier Source: secondary_id
15-9431
Identifier Type: -
Identifier Source: org_study_id