Aging, Deglutition, Healthy Swallowing
Conditions
Keywords
Swallowing, Deglutition
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.
Interventions
OTHERStarch-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.
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.
COMBINATION_PRODUCTBarium concentration
Commercially available barium products diluted to different concentrations (i.e., 20% w/v, 40% w/v) through the addition of water
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
University Health Network, Toronto
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diameter of Upper Esophageal Sphincter Opening | 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 | 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. |
| Number of Participants With Unsafe Swallowing | 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 | 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 | 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) | 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 | 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 | 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) | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amplitude of Tongue-Palate Pressure | Baseline (single timepoint only) | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Adults Healthy adults aged 18-82. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Healthy Adults |
|---|---|
| Age, Continuous | 46 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 77 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 61 Participants |
| Region of Enrollment Canada | 80 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
Primary
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).
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data were missing for 4 participants for thin liquid barium and for 3 participants for the remaining consistencies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Amount of Residue in the Pharynx | 0.2 % of the (C2-4)squared scalar reference |
| Slightly Thick Liquid Barium | Amount of Residue in the Pharynx | 0.3 % of the (C2-4)squared scalar reference |
| Mildly Thick Liquid Barium | Amount of Residue in the Pharynx | 0.6 % of the (C2-4)squared scalar reference |
| Moderately Thick Liquid Barium | Amount of Residue in the Pharynx | 0.2 % of the (C2-4)squared scalar reference |
| Extremely Thick Liquid Barium | Amount of Residue in the Pharynx | 0.1 % of the (C2-4)squared scalar reference |
Primary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data were missing for thin liquid in 4 participants, and for the remaining consistencies in 3 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Degree of Pharyngeal Constriction | 1 % squared C2-C4 cervical spine length |
| Slightly Thick Liquid Barium | Degree of Pharyngeal Constriction | 1.2 % squared C2-C4 cervical spine length |
| Mildly Thick Liquid Barium | Degree of Pharyngeal Constriction | 1.2 % squared C2-C4 cervical spine length |
| Moderately Thick Liquid Barium | Degree of Pharyngeal Constriction | 0.7 % squared C2-C4 cervical spine length |
| Extremely Thick Liquid Barium | Degree of Pharyngeal Constriction | 0.2 % squared C2-C4 cervical spine length |
Primary
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).
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data for thin liquid were missing for 4 participants, and for 3 participants on the remaining consistencies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Diameter of Upper Esophageal Sphincter Opening | 21 % of the C2-C4 Cervical Spine Scalar |
| Slightly Thick Liquid Barium | Diameter of Upper Esophageal Sphincter Opening | 19 % of the C2-C4 Cervical Spine Scalar |
| Mildly Thick Liquid Barium | Diameter of Upper Esophageal Sphincter Opening | 19 % of the C2-C4 Cervical Spine Scalar |
| Moderately Thick Liquid Barium | Diameter of Upper Esophageal Sphincter Opening | 15 % of the C2-C4 Cervical Spine Scalar |
| Extremely Thick Liquid Barium | Diameter of Upper Esophageal Sphincter Opening | 16 % of the C2-C4 Cervical Spine Scalar |
Primary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data were missing for 4 participants on thin liquid and for 3 participants on the remaining consistencies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter | 100 milliseconds |
| Slightly Thick Liquid Barium | Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter | 133 milliseconds |
| Mildly Thick Liquid Barium | Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter | 133 milliseconds |
| Moderately Thick Liquid Barium | Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter | 167 milliseconds |
| Extremely Thick Liquid Barium | Duration of the Time Interval Between Onset of the Hyoid Burst and Opening of the Upper Esophageal Sphincter | 167 milliseconds |
Primary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data were missing for 4 participants on thin liquid and for 3 participants on the remaining consistencies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway (Time-to-Laryngeal-Vestibule-Closure) | 133 milliseconds |
| Slightly Thick Liquid Barium | Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway (Time-to-Laryngeal-Vestibule-Closure) | 133 milliseconds |
| Mildly Thick Liquid Barium | Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway (Time-to-Laryngeal-Vestibule-Closure) | 133 milliseconds |
| Moderately Thick Liquid Barium | Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway (Time-to-Laryngeal-Vestibule-Closure) | 167 milliseconds |
| Extremely Thick Liquid Barium | Duration of the Time Interval Between Onset of the Pharyngeal Swallow and Closure of the Entrance to the Airway (Time-to-Laryngeal-Vestibule-Closure) | 133 milliseconds |
Primary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data were missing for 4 participants on thin liquid and for 3 participants on the other consistencies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow (Swallow Reaction Time) | 133 milliseconds |
| Slightly Thick Liquid Barium | Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow (Swallow Reaction Time) | 133 milliseconds |
| Mildly Thick Liquid Barium | Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow (Swallow Reaction Time) | 167 milliseconds |
| Moderately Thick Liquid Barium | Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow (Swallow Reaction Time) | 267 milliseconds |
| Extremely Thick Liquid Barium | Duration of the Time Interval Between the Bolus Entering the Pharynx and Onset of the Pharyngeal Swallow (Swallow Reaction Time) | 367 milliseconds |
Primary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data were missing for 4 participants on thin liquid and for 3 participants on the remaining consistencies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Duration of Upper Esophageal Sphincter Opening | 467 milliseconds |
| Slightly Thick Liquid Barium | Duration of Upper Esophageal Sphincter Opening | 467 milliseconds |
| Mildly Thick Liquid Barium | Duration of Upper Esophageal Sphincter Opening | 467 milliseconds |
| Moderately Thick Liquid Barium | Duration of Upper Esophageal Sphincter Opening | 400 milliseconds |
| Extremely Thick Liquid Barium | Duration of Upper Esophageal Sphincter Opening | 400 milliseconds |
Primary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data were missing for 4 participants for thin liquid and for 3 participants for the remaining consistencies.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Laryngeal Vestibule Closure Duration | 467 milliseconds |
| Slightly Thick Liquid Barium | Laryngeal Vestibule Closure Duration | 467 milliseconds |
| Mildly Thick Liquid Barium | Laryngeal Vestibule Closure Duration | 467 milliseconds |
| Moderately Thick Liquid Barium | Laryngeal Vestibule Closure Duration | 434 milliseconds |
| Extremely Thick Liquid Barium | Laryngeal Vestibule Closure Duration | 434 milliseconds |
Primary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due data quality issues, partial data were missing for thin liquid for 4 participants, and for 3 participants for the remaining consistencies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thin Liquid Barium | Number of Participants Displaying More Than 2 Swallows Per Bolus | 6 Participants |
| Slightly Thick Liquid Barium | Number of Participants Displaying More Than 2 Swallows Per Bolus | 2 Participants |
| Mildly Thick Liquid Barium | Number of Participants Displaying More Than 2 Swallows Per Bolus | 2 Participants |
| Moderately Thick Liquid Barium | Number of Participants Displaying More Than 2 Swallows Per Bolus | 3 Participants |
| Extremely Thick Liquid Barium | Number of Participants Displaying More Than 2 Swallows Per Bolus | 3 Participants |
Primary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. Due data quality issues, partial data were missing for thin liquid for 4 participants, and for 3 participants for the remaining consistencies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thin Liquid Barium | Number of Participants With Unsafe Swallowing | 7 Participants |
| Slightly Thick Liquid Barium | Number of Participants With Unsafe Swallowing | 1 Participants |
| Mildly Thick Liquid Barium | Number of Participants With Unsafe Swallowing | 3 Participants |
| Moderately Thick Liquid Barium | Number of Participants With Unsafe Swallowing | 0 Participants |
| Extremely Thick Liquid Barium | Number of Participants With Unsafe Swallowing | 0 Participants |
Primary
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.
Time frame: Single timepoint (baseline only)
Population: A sample of 80 adults was enrolled. Due to data quality issues, data were missing for 2 participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Thin Liquid Barium | Pharyngeal Area at Rest | 59 % of the squared C2-C4 length scalar |
Secondary
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.
Time frame: Baseline (single timepoint only)
Population: A sample of 80 adults was enrolled. This parameter was only collected and analyzed in 40 of those participants, aged 21-59. Due to data quality issues, data were missing for 2 participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Thin Liquid Barium | Amplitude of Tongue-Palate Pressure | 16.53 mmHg | Standard Error 2.21 |
| Slightly Thick Liquid Barium | Amplitude of Tongue-Palate Pressure | 25.51 mmHg | Standard Error 3.58 |
| Mildly Thick Liquid Barium | Amplitude of Tongue-Palate Pressure | 28.61 mmHg | Standard Error 3.47 |
| Moderately Thick Liquid Barium | Amplitude of Tongue-Palate Pressure | 51.89 mmHg | Standard Error 8.83 |