Clinical trial NCT04114617: Physiological Flow of Liquids in Healthy Swallowing
Official title: Physiological Flow of Liquids in Healthy Swallowing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition
Healthy Swallowing
Aging
Keywords: Swallowing
Deglutition
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2019-10-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief 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.

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

Primary outcomes:
measure: Number of Participants With Unsafe Swallowing
timeFrame: Baseline (single timepoint only)
measure: Amount of Residue in the Pharynx
timeFrame: Baseline (single timepoint only)
measure: Number of Participants Displaying More Than 2 Swallows Per Bolus
timeFrame: Baseline (single timepoint only)
measure: Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow ("Swallow Reaction Time")
timeFrame: Baseline (single timepoint only)
measure: Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter
timeFrame: Baseline (single timepoint only)
measure: Duration of Upper Esophageal Sphincter Opening
timeFrame: Baseline (single timepoint only)
measure: Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway ("Time-to-Laryngeal-Vestibule-Closure")
timeFrame: Baseline (single timepoint only)
measure: Laryngeal Vestibule Closure Duration
timeFrame: Baseline (single timepoint only)
measure: Degree of Pharyngeal Constriction
timeFrame: Baseline (single timepoint only)
measure: Diameter of Upper Esophageal Sphincter Opening
timeFrame: Baseline (single timepoint only)
measure: Pharyngeal Area at Rest
timeFrame: Single timepoint (baseline only)
Secondary outcomes:
measure: Amplitude of Tongue-Palate Pressure
timeFrame: Baseline (single timepoint only)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Rehabilitation Institute
state: Ontario
Study officials:
affiliation: KITE - Toronto Rehabilitation Institute, University Health Network
name: Catriona Steele, PhD
role: PRINCIPAL_INVESTIGATOR
References: