Dysphagia, OropharyngealNIA_RVNCT05497219
Reference Values for Videofluoroscopic Measures of Swallowing
A study testing Videofluoroscopic Swallowing Study (VF) in people with Dysphagia, Oropharyngeal, run by University Health Network, Toronto at 5 sites in 2 countries.
Trial summary
Dysphagia (swallowing impairment) is a serious health condition seen in many age-related disease and injury processes. Although videofluoroscopy (VF) is an international "gold standard" dysphagia diagnostic exam, there is a paucity of available normative physiologic VF reference values in healthy adults across the age… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Oropharyngeal
- What is being tested?
- Videofluoroscopic Swallowing Study (VF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 15 Nov 2022to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Healthy Volunteers: no history of swallowing difficulties.
- Clinical cohorts: physician confirmed diagnosis of the condition of interest plus symptoms of swallowing difficult, defined as a score >/=200 on the Sydney Swallow Questionnaire.
Who cannot join
- cognitive communication difficulties that may hinder comprehension of the study documents
- known allergies to latex, due to the possibility that these items will come into contact with the oral mucosa during data collection
- current pregnancy
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites
University of Cincinnati Medical Center
Cincinnati, Ohio, 45221
The Ohio State University
Columbus, Ohio, 43212
University of Florida
Gainesville, Florida, 32611
Canada2 sites
McMaster University
Hamilton, Ontario
University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: Establishing Reference Values and Clinical Decision Points for Quantitative Videofluoroscopic Measures of Swallowing
Dysphagia (swallowing impairment) is a serious health condition seen in many age-related disease and injury processes. Although videofluoroscopy (VF) is an international "gold standard" dysphagia diagnostic exam, there is a paucity of available normative physiologic VF reference values in healthy adults across the age span to guide interpretation of these examinations. In this project, the investigators will extend previous work on the quantitative measurement of swallowing physiology from VF examinations to establish reference values for swallowing in healthy adults, and to identify clinical decision point values for differentiating healthy swallowing across the age span from disordered swallowing in several high-risk clinical populations to study dysphagia.
Read the detailed description
Dysphagia (swallowing impairment) is a serious health condition seen in many age-related disease and injury processes. Although videofluoroscopy (VF) is an international "gold standard" dysphagia diagnostic exam, there is a paucity of available normative physiologic VF reference values in healthy adults across the age span to guide interpretation of this examination. This fundamental gap in knowledge contributes to poor agreement in the identification of swallowing impairment and its underlying mechanisms. To enable better dysphagia diagnostics, there is a critical need to establish reference values for VF swallowing measures across the healthy age span.
In a previous study, the investigators developed a rigorous method for measuring swallowing physiology from VF: the Analysis of Swallowing Physiology: Events, Kinematics and Timing (ASPEKT Method). That study led to publication of initial ASPEKT reference values from 40 young healthy adults (<60 years) and preliminary analyses comparing data from healthy older adults and small cohorts of adults with dysphagia to these reference data.
In this project, the investigtors will:
- validate the ASPEKT Method healthy reference values for swallowing across the adult life span; and
- profile swallowing patho-physiology in clinical groups where dysphagia is a cause of morbidity to identify clinical decision points that can be used for diagnosis and outcome measurement.
This study will explore the following research questions:
Research Question 1: Will > 5% of healthy adult participants in a new sample show ASPEKT values outside the common reference interval calculated in a prior sample? • VF measures will be collected in a prospective sample of 280 healthy adults, controlling for sex, age, and bolus consistency. Updated reference interval boundaries for healthy swallowing will be calculated.
Research Question 2: Do specific clinical conditions present with specific patterns of swallowing pathophysiology?
- VF measures will be prospectively collected in 3 high-risk dysphagia cohorts: adults with Parkinson Disease, Chronic Obstructive Pulmonary Disease, adults in the acute stage post-stroke. Values for these clinical cohorts will be compared to age- and sex-matched reference values from healthy participants. This will delineate swallowing impairment profiles to inform clinical decision points for diagnosis.
- Conditions
- Dysphagia, Oropharyngeal
- Being tested
- Videofluoroscopic Swallowing Study (VF)
- Keywords
- Deglutition
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videofluoroscopic Swallowing Study (VF)Diagnostic test
A videofluoroscopy (VF) is a dynamic radiological evaluation of swallowing in which the participant swallows liquid or food boluses of different consistencies prepared with barium contrast. The x-rays are recorded at 30 frames per second.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Other | Adults aged 18 or older with no history of swallowing impairment Receives: Diagnostic Test: Videofluoroscopic Swallowing Study (VF) |
| Parkinson Disease | Other | Adults with a neurologist-confirmed diagnosis of Parkinson Disease who also report symptoms of swallowing impairment, defined as a score >/= 200 on the Sydney Swallow Questionnaire. Receives: Diagnostic Test: Videofluoroscopic Swallowing Study (VF) |
| Chronic Obstructive Pulmonary Disease | Other | Adults with a respirologist-confirmed diagnosis of Chronic Obstructive Pulmonary Disease who also report symptoms of swallowing impairment, defined as a score >/= 200 on the Sydney Swallow Questionnaire. Receives: Diagnostic Test: Videofluoroscopic Swallowing Study (VF) |
| Acute Stroke | Other | Adult inpatients in the acute stage post stroke who are referred for swallowing assessment. Receives: Diagnostic Test: Videofluoroscopic Swallowing Study (VF) |
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 requires the ability to protect the airway to prevent penetration-aspiration (the entry of food or liquid material into the airway during swallowing). Swallowing safety will be 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). The frequency (count) of participants showing scores > 2 will be reported by bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquids).
Measured: Baseline
Number of participants with impaired swallowing efficiency
Swallowing efficiency requires the ability to move a bolus of food or liquid from the mouth through the pharynx into the esophagus in a single swallow without leaving residue behind in the pharynx. Residue is material remaining behind in the pharynx after the swallow. Residue will be measured 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 of the 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, i.e. less than 1% (C2-4)squared. The frequency (count) of participants showing residue above this threshold will be reported by bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquids).
Measured: Baseline
Number of participants with delayed airway closure ("Time-to-laryngeal-vestibule-closure")
Swallowing safety requires the ability to protect the airway to prevent penetration-aspiration (the entry of food or liquid material into the airway during swallowing). Closure of the entrance to the airway ("laryngeal vestibule closure" or LVC) must be achieved in a timely manner. Time-to-LVC will be measured, i.e., the time interval between onset of the pharyngeal swallow (i.e. onset of the hyoid burst movement) and the first frame showing the most-complete closure of the laryngeal vestibule. In healthy adults, the upper limits (97.5th percentile value) for this measure are currently reported to be 267 ms on thin liquids, 367 ms on slightly thick liquids, 367 ms on mildly thick liquids, 300 ms on moderately thick liquids and 267 ms on extremely thick liquids. The frequency (count) of participants displaying time-to-LVC measures above these limits will be reported by bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid).
Measured: Baseline
Number of participants with poor pharyngeal constriction
Efficient clearance of a bolus of food or liquid through the pharynx in swallowing requires constriction of the pharynx. In healthy adults, there is typically no unobliterated space visible in the pharynx on a lateral view x-ray image on the frame of maximum constriction. ImageJ software will be used to measure the area of unobliterated pharyngeal space, which is expressed as a % of an anatomical reference scalar defined as the squared length of the C2-C4 cervical spine [%(C2-4)squared]. Larger unobliterated area reflects impairment in pharyngeal constriction. In healthy adults, the upper limits (97.5th percentile) for this measure are currently reported to be 6.2%(C2-4)squared on thin, 5% on slightly thick, 7.5% on mildly thick, 4.9% on moderately thick and 3.8% on extremely thick liquids. The frequency (count) of participants with pharyngeal constriction area above these limits will be reported by bolus consistency.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start15 Nov 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dysphagia, OropharyngealStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florida, McMaster University, National Institute on Aging (NIA), Ohio State University, University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Catriona M Steele, PhD, Principal investigator, University Health Network, TorontoEmily K Plowman, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497219
- Sponsor's protocol ID
- 21-6019
- Other IDs
- R01AG077481
- Acronym
- NIA_RV
- Status last verified
- Sep 2025
- First submitted
- 8 Aug 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu D, Mancopes R, Milne H, Peladeau-Pigeon M, Boyce K, Chan H, Folsom M, Abrams SW, Namasivayam-MacDonald AM, Plowman EK, Steele CM. The Dynamics of Pharyngeal Shortening in Healthy Swallowing: Effects of Sex, Age, Bolus Volume and Consistency. J Oral Rehabil. 2026 Jul 6. doi: 10.1111/joor.70257. Online ahead of print.
PubMed 42409758
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing Reference Values and Clinical Decision Points for Quantitative Videofluoroscopic Measures of Swallowing
- ClinicalTrials.gov ID
- NCT05497219
- Acronym / sponsor ID
- NIA_RV / 21-6019
- Conditions
- Dysphagia, Oropharyngeal
- Keywords
- Deglutition
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Florida, McMaster University, National Institute on Aging (NIA), Ohio State University, University of Cincinnati
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dysphagia (swallowing impairment) is a serious health condition seen in many age-related disease and injury processes. Although videofluoroscopy (VF) is an international "gold standard" dysphagia diagnostic exam, there is a paucity of available normative physiologic VF reference values in healthy adults across the age span to guide interpretation of these examinations. In this project, the investigators will extend previous work on the quantitative measurement of swallowing physiology from VF examinations to establish reference values for swallowing in healthy adults, and to identify clinical decision point values for differentiating healthy swallowing across the age span from disordered swallowing in several high-risk clinical populations to study dysphagia.
Detailed description
Dysphagia (swallowing impairment) is a serious health condition seen in many age-related disease and injury processes. Although videofluoroscopy (VF) is an international "gold standard" dysphagia diagnostic exam, there is a paucity of available normative physiologic VF reference values in healthy adults across the age span to guide interpretation of this examination. This fundamental gap in knowledge contributes to poor agreement in the identification of swallowing impairment and its underlying mechanisms. To enable better dysphagia diagnostics, there is a critical need to establish reference values for VF swallowing measures across the healthy age span.
In a previous study, the investigators developed a rigorous method for measuring swallowing physiology from VF: the Analysis of Swallowing Physiology: Events, Kinematics and Timing (ASPEKT Method). That study led to publication of initial ASPEKT reference values from 40 young healthy adults (<60 years) and preliminary analyses comparing data from healthy older adults and small cohorts of adults with dysphagia to these reference data.
In this project, the investigtors will:
- validate the ASPEKT Method healthy reference values for swallowing across the adult life span; and
- profile swallowing patho-physiology in clinical groups where dysphagia is a cause of morbidity to identify clinical decision points that can be used for diagnosis and outcome measurement.
This study will explore the following research questions:
Research Question 1: Will > 5% of healthy adult participants in a new sample show ASPEKT values outside the common reference interval calculated in a prior sample? • VF measures will be collected in a prospective sample of 280 healthy adults, controlling for sex, age, and bolus consistency. Updated reference interval boundaries for healthy swallowing will be calculated.
Research Question 2: Do specific clinical conditions present with specific patterns of swallowing pathophysiology?
- VF measures will be prospectively collected in 3 high-risk dysphagia cohorts: adults with Parkinson Disease, Chronic Obstructive Pulmonary Disease, adults in the acute stage post-stroke. Values for these clinical cohorts will be compared to age- and sex-matched reference values from healthy participants. This will delineate swallowing impairment profiles to inform clinical decision points for diagnosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | Other | Diagnostic Test: Videofluoroscopic Swallowing Study (VF)Adults aged 18 or older with no history of swallowing impairment |
| Parkinson Disease | Other | Diagnostic Test: Videofluoroscopic Swallowing Study (VF)Adults with a neurologist-confirmed diagnosis of Parkinson Disease who also report symptoms of swallowing impairment, defined as a score >/= 200 on the Sydney Swallow Questionnaire. |
| Chronic Obstructive Pulmonary Disease | Other | Diagnostic Test: Videofluoroscopic Swallowing Study (VF)Adults with a respirologist-confirmed diagnosis of Chronic Obstructive Pulmonary Disease who also report symptoms of swallowing impairment, defined as a score >/= 200 on the Sydney Swallow Questionnaire. |
| Acute Stroke | Other | Diagnostic Test: Videofluoroscopic Swallowing Study (VF)Adult inpatients in the acute stage post stroke who are referred for swallowing assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Volunteers: no history of swallowing difficulties.
- Clinical cohorts: physician confirmed diagnosis of the condition of interest plus symptoms of swallowing difficult, defined as a score >/=200 on the Sydney Swallow Questionnaire.
Key exclusion criteria (3 listed)
- cognitive communication difficulties that may hinder comprehension of the study documents
- known allergies to latex, due to the possibility that these items will come into contact with the oral mucosa during data collection
- current pregnancy
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 |
|---|---|---|
| Videofluoroscopic Swallowing Study (VF)A videofluoroscopy (VF) is a dynamic radiological evaluation of swallowing in which the participant swallows liquid or food boluses of different consistencies prepared with barium contrast. The x-rays are recorded at 30 frames per second. | Diagnostic test | Acute Stroke, Chronic Obstructive Pulmonary Disease, Healthy adults, Parkinson Disease |
Primary outcome
Number of participants with unsafe swallowing
Time frame: Baseline
Swallowing safety requires the ability to protect the airway to prevent penetration-aspiration (the entry of food or liquid material into the airway during swallowing). Swallowing safety will be 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). The frequency (count) of participants showing scores > 2 will be reported by bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquids).
Number of participants with impaired swallowing efficiency
Time frame: Baseline
Swallowing efficiency requires the ability to move a bolus of food or liquid from the mouth through the pharynx into the esophagus in a single swallow without leaving residue behind in the pharynx. Residue is material remaining behind in the pharynx after the swallow. Residue will be measured 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 of the 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, i.e. less than 1% (C2-4)squared. The frequency (count) of participants showing residue above this threshold will be reported by bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquids).
Number of participants with delayed airway closure ("Time-to-laryngeal-vestibule-closure")
Time frame: Baseline
Swallowing safety requires the ability to protect the airway to prevent penetration-aspiration (the entry of food or liquid material into the airway during swallowing). Closure of the entrance to the airway ("laryngeal vestibule closure" or LVC) must be achieved in a timely manner. Time-to-LVC will be measured, i.e., the time interval between onset of the pharyngeal swallow (i.e. onset of the hyoid burst movement) and the first frame showing the most-complete closure of the laryngeal vestibule. In healthy adults, the upper limits (97.5th percentile value) for this measure are currently reported to be 267 ms on thin liquids, 367 ms on slightly thick liquids, 367 ms on mildly thick liquids, 300 ms on moderately thick liquids and 267 ms on extremely thick liquids. The frequency (count) of participants displaying time-to-LVC measures above these limits will be reported by bolus consistency (thin, slightly thick, mildly thick, moderately thick and extremely thick liquid).
Number of participants with poor pharyngeal constriction
Time frame: Baseline
Efficient clearance of a bolus of food or liquid through the pharynx in swallowing requires constriction of the pharynx. In healthy adults, there is typically no unobliterated space visible in the pharynx on a lateral view x-ray image on the frame of maximum constriction. ImageJ software will be used to measure the area of unobliterated pharyngeal space, which is expressed as a % of an anatomical reference scalar defined as the squared length of the C2-C4 cervical spine [%(C2-4)squared]. Larger unobliterated area reflects impairment in pharyngeal constriction. In healthy adults, the upper limits (97.5th percentile) for this measure are currently reported to be 6.2%(C2-4)squared on thin, 5% on slightly thick, 7.5% on mildly thick, 4.9% on moderately thick and 3.8% on extremely thick liquids. The frequency (count) of participants with pharyngeal constriction area above these limits will be reported by bolus consistency.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Derived from this study: PubMed 42409758Yu D, Mancopes R, Milne H, Peladeau-Pigeon M, Boyce K, Chan H, Folsom M, Abrams SW, Namasivayam-MacDonald AM, Plowman EK, Steele CM. The Dynamics of Pharyngeal Shortening in Healthy Swallowing: Effects of Sex, Age, Bolus Volume and Consistency. J Oral Rehabil. 2026 Jul 6. doi: 10.1111/joor.70257. Online ahead of print.
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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.
Catriona M Steele, PhD principal investigator
University Health Network, Toronto
Emily K Plowman, PhD principal investigator
Ohio State University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videofluoroscopic Swallowing Study (VF) in people with Dysphagia, Oropharyngeal, run by University Health Network, Toronto at 5 sites in 2 countries.
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 2 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, 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?
This study is still under way. Results are not available in the source record yet.
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497219, which also lists 1 linked publication.
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 14 May 2026.