DeglutitionNCT04114617
Physiological Flow of Liquids in Healthy Swallowing
An observational study of Deglutition and Healthy Swallowing, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Deglutition, Healthy Swallowing, Aging
- What is being tested?
- Starch-thickened liquids, Xanthan-gum thickened liquids and Barium concentration
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2016to 31 Dec 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- healthy adults
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Deglutition, Healthy Swallowing, Aging
- Being tested
- Starch-thickened liquids, Xanthan-gum thickened liquids, Barium concentration
- Keywords
- Swallowing, Deglutition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starch-thickened liquidsOther
Also called Nestle Resource ThickenUp
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 liquidsOther
Also called Nestle Resource ThickenUp Clear
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 concentrationCombination product
Also called Bracco E-Z-Paque barium powder; Bracco E-Z-HD barium suspension; Bracco Polibar Plus liquid barium suspension
Commercially available barium products diluted to different concentrations (i.e., 20% w/v, 40% w/v) through the addition of water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Starch-thickened liquids; Other: Xanthan-gum thickened liquids; Combination Product: Barium concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Unsafe Swallowing
Swallowing safety was measured using the Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels > 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (< 3 vs >/= 3). We will report the frequency (count) of participants showing scores > 2 by bolus consistency.
Measured: Baseline (single timepoint only)
Amount of Residue in the Pharynx
Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. In healthy swallowing, residue is expected to be minimal. We report median values and 97.5% confidence intervals for amount of residue by consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquids).
Measured: Baseline (single timepoint only)
Number of Participants Displaying More Than 2 Swallows Per Bolus
The number of swallows needed to clear a single bolus will be counted. 1-2 swallows is considered efficient, while > 2 for a single bolus is considered inefficient. We report the frequency (count) of participants displaying > 2 swallows per bolus by consistency.
Measured: Baseline (single timepoint only)
Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow ("Swallow Reaction Time")
The time interval between the first frame showing the bolus entering the pharynx (passing the ramus of the mandible) and the first frame showing onset of the hyoid burst movement in swallowing, calculated in milliseconds. We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Longer time intervals reflect delays in initiating the pharyngeal swallow.
Measured: Baseline (single timepoint only)
Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter
The time interval between the first frame showing onset of the hyoid burst movement in swallowing and the first frame showing opening of the upper esophageal sphincter, calculated in milliseconds. We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Longer time intervals reflect a delay in opening of the upper esophageal sphincter.
Measured: Baseline (single timepoint only)
Duration of Upper Esophageal Sphincter Opening
The time interval between the first frame showing opening of the upper esophageal sphincter and the first subsequent frame showing closure of the upper esophageal sphincter behind the tail of the bolus, calculated (in milliseconds). We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Shorter durations of upper esophageal sphincter opening reflect inadequate durations of opening to allow material to pass through the sphincter from the pharynx into the esophagus.
Measured: Baseline (single timepoint only)
Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway ("Time-to-Laryngeal-Vestibule-Closure")
The time interval between the first frame showing onset of the hyoid burst movement in swallowing and the first frame showing closure of the laryngeal vestibule, calculated in milliseconds. We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Longer time intervals reflect delays in achieving airway closure.
Measured: Baseline (single timepoint only)
Laryngeal Vestibule Closure Duration
The time interval between the first frame showing closure of the entrance to the airway (laryngeal vestibule closure onset) and the first subsequent frame showing opening of the entrance to the airway (laryngeal vestibule closure offset) calculated in milliseconds. We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Shorter durations of laryngeal vestibule closure reflect premature termination of airway protection.
Measured: Baseline (single timepoint only)
Degree of Pharyngeal Constriction
During swallowing, the muscles of the pharynx contract to achieve constriction (closure) of the pharynx behind the bolus. The squeezing and pressure generated by this action help to move the bolus downwards through the pharynx. We measured the degree of pharyngeal constriction by identifying the frame of greatest pharyngeal constriction, and tracing the area of any unobliterated pharyngeal space on lateral view x-ray (in pixels, using ImageJ software). The resulting area measure was then divided by the squared length of the C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, enabling the comparison of constriction across different people with different neck length and pharynx size. In healthy swallowing, constriction is expected to be complete, with larger measures reflecting incomplete or poor constriction. We report median values and 97.5% confidence intervals for pharyngeal constriction by consistency.
Measured: Baseline (single timepoint only)
Diameter of Upper Esophageal Sphincter Opening
During swallowing, the upper esophageal sphincter opens to allow the bolus to move from the pharynx into the esophagus. Narrow opening of the sphincter may obstruct bolus flow. We measured the degree (diameter) of upper esophageal sphincter opening on the frame of maximum distension. Line measurements were made in Image J software. This line measure was then divided by the length of the C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, enabling the comparison of constriction across different people with different neck length and pharynx size. We report median values and 97.5% confidence intervals for pharyngeal constriction by consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid).
Measured: Baseline (single timepoint only)
Pharyngeal Area at Rest
The area of the pharynx was measured, in pixels (using ImageJ software), on a lateral view videofluoroscopic image showing the pharynx at rest. The resulting area measure was then divided by the squared length of the C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, enabling the comparison of pharyngeal size across different people with different neck length. Larger pharyngeal area measures may reflect atrophy of the pharyngeal muscles while smaller pharyngeal area may reflect narrowing due to edema.We report median values and 97.5% confidence intervals for pharyngeal area.
Measured: Single timepoint (baseline only)
Secondary outcomes (1)
Amplitude of Tongue-Palate Pressure
During swallowing, the tongue rises to contact the hard palate, generating pressure that squeezes the bolus backwards through the mouth towards the pharynx. The amplitude of tongue-palate pressure were measured continuously throughout swallowing using the KayPentax Digital Swallow Workstation Swallowing Signals Lab 3-bulb tongue pressure array, and the highest (peak) pressure was identified for each swallow. We will report mean values and standard error for peak pressure by bolus consistency (thin, slightly thick, mildly thick and moderately thick liquid). Higher amplitudes of pressure represent greater force for bolus propulsion.
Measured: Baseline (single timepoint only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Jan 2016
- Primary completion12 Sep 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeglutitionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Catriona Steele, PhD, Principal investigator, KITE - Toronto Rehabilitation Institute, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114617
- Sponsor's protocol ID
- 15-9431
- Other IDs
- 5R01DC011020, CAPCR 15-9431 (NIH_HV)
- Status last verified
- Nov 2022
- First submitted
- 27 Sep 2019
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Flow of Liquids in Healthy Swallowing
- ClinicalTrials.gov ID
- NCT04114617
- Acronym / sponsor ID
- 15-9431
- Conditions
- Deglutition, Healthy Swallowing, Aging
- Keywords
- Swallowing, Deglutition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 12 Sep 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 21 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | – | Other: Starch-thickened liquids, Other: Xanthan-gum thickened liquids, Combination Product: Barium concentrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starch-thickened liquidsAlso: Nestle Resource ThickenUpThickener 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. | Other | Healthy Adults |
| Xanthan-gum thickened liquidsAlso: Nestle Resource ThickenUp ClearThickener 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. | Other | Healthy Adults |
| Barium concentrationAlso: Bracco E-Z-Paque barium powder; Bracco E-Z-HD barium suspension; Bracco Polibar Plus liquid barium suspensionCommercially available barium products diluted to different concentrations (i.e., 20% w/v, 40% w/v) through the addition of water | Combination product | Healthy Adults |
Primary outcome
Number of Participants With Unsafe Swallowing
Time frame: Baseline (single timepoint only)
Swallowing safety was measured using the Penetration-Aspiration Scale, an 8-point categorical scale which captures the depth to which any material enters the airway and whether or not the material is ejected. Levels 1 and 2 on the scale are considered safe, while levels > 2 are considered unsafe. Actual scale scores (1-8) will be recorded and then converted to binary categorical scores (< 3 vs >/= 3). We will report the frequency (count) of participants showing scores > 2 by bolus consistency.
Amount of Residue in the Pharynx
Time frame: Baseline (single timepoint only)
Residue is material remaining behind in the pharynx after the swallow. We measured residue by tracing the area of barium visible on a lateral view x-ray (in pixels, using ImageJ software) and dividing that area by the squared length C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, and enables the comparison of residue severity across different people with different neck length and pharynx size. In healthy swallowing, residue is expected to be minimal. We report median values and 97.5% confidence intervals for amount of residue by consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquids).
Number of Participants Displaying More Than 2 Swallows Per Bolus
Time frame: Baseline (single timepoint only)
The number of swallows needed to clear a single bolus will be counted. 1-2 swallows is considered efficient, while > 2 for a single bolus is considered inefficient. We report the frequency (count) of participants displaying > 2 swallows per bolus by consistency.
Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow ("Swallow Reaction Time")
Time frame: Baseline (single timepoint only)
The time interval between the first frame showing the bolus entering the pharynx (passing the ramus of the mandible) and the first frame showing onset of the hyoid burst movement in swallowing, calculated in milliseconds. We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Longer time intervals reflect delays in initiating the pharyngeal swallow.
Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter
Time frame: Baseline (single timepoint only)
The time interval between the first frame showing onset of the hyoid burst movement in swallowing and the first frame showing opening of the upper esophageal sphincter, calculated in milliseconds. We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Longer time intervals reflect a delay in opening of the upper esophageal sphincter.
Duration of Upper Esophageal Sphincter Opening
Time frame: Baseline (single timepoint only)
The time interval between the first frame showing opening of the upper esophageal sphincter and the first subsequent frame showing closure of the upper esophageal sphincter behind the tail of the bolus, calculated (in milliseconds). We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Shorter durations of upper esophageal sphincter opening reflect inadequate durations of opening to allow material to pass through the sphincter from the pharynx into the esophagus.
Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway ("Time-to-Laryngeal-Vestibule-Closure")
Time frame: Baseline (single timepoint only)
The time interval between the first frame showing onset of the hyoid burst movement in swallowing and the first frame showing closure of the laryngeal vestibule, calculated in milliseconds. We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Longer time intervals reflect delays in achieving airway closure.
Laryngeal Vestibule Closure Duration
Time frame: Baseline (single timepoint only)
The time interval between the first frame showing closure of the entrance to the airway (laryngeal vestibule closure onset) and the first subsequent frame showing opening of the entrance to the airway (laryngeal vestibule closure offset) calculated in milliseconds. We report median values and 97.5% confidence intervals for each bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid barium). Shorter durations of laryngeal vestibule closure reflect premature termination of airway protection.
Degree of Pharyngeal Constriction
Time frame: Baseline (single timepoint only)
During swallowing, the muscles of the pharynx contract to achieve constriction (closure) of the pharynx behind the bolus. The squeezing and pressure generated by this action help to move the bolus downwards through the pharynx. We measured the degree of pharyngeal constriction by identifying the frame of greatest pharyngeal constriction, and tracing the area of any unobliterated pharyngeal space on lateral view x-ray (in pixels, using ImageJ software). The resulting area measure was then divided by the squared length of the C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, enabling the comparison of constriction across different people with different neck length and pharynx size. In healthy swallowing, constriction is expected to be complete, with larger measures reflecting incomplete or poor constriction. We report median values and 97.5% confidence intervals for pharyngeal constriction by consistency.
Diameter of Upper Esophageal Sphincter Opening
Time frame: Baseline (single timepoint only)
During swallowing, the upper esophageal sphincter opens to allow the bolus to move from the pharynx into the esophagus. Narrow opening of the sphincter may obstruct bolus flow. We measured the degree (diameter) of upper esophageal sphincter opening on the frame of maximum distension. Line measurements were made in Image J software. This line measure was then divided by the length of the C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, enabling the comparison of constriction across different people with different neck length and pharynx size. We report median values and 97.5% confidence intervals for pharyngeal constriction by consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid).
Pharyngeal Area at Rest
Time frame: Single timepoint (baseline only)
The area of the pharynx was measured, in pixels (using ImageJ software), on a lateral view videofluoroscopic image showing the pharynx at rest. The resulting area measure was then divided by the squared length of the C2-C4 cervical spine. This cervical spine scalar provides a common anatomical reference that is a proxy for pharyngeal size, enabling the comparison of pharyngeal size across different people with different neck length. Larger pharyngeal area measures may reflect atrophy of the pharyngeal muscles while smaller pharyngeal area may reflect narrowing due to edema.We report median values and 97.5% confidence intervals for pharyngeal area.
1 secondary outcome
Amplitude of Tongue-Palate Pressure
Time frame: Baseline (single timepoint only)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catriona Steele, PhD principal investigator
KITE - Toronto Rehabilitation Institute, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deglutition and Healthy Swallowing, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Unsafe Swallowing (time frame: Baseline (single timepoint only)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022; AzTrials last refreshed its copy on 26 Oct 2026.