Reference Values for Videofluoroscopic Measures of Swallowing

NCT05497219 | Enrolling By Invitation

• 2 other identifiers: 21-6019R01AG077481
• Study Type: interventional
• Target: 580
• Locations: 2 countries
• Sites: 5

Brief 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 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.

Conditions

Dysphagia, Oropharyngeal

Keywords

Deglutition

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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).

  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.

  Baseline

Study Arms (4)

Healthy adults

OTHER

Adults aged 18 or older with no history of swallowing impairment

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.

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.

Diagnostic Test: Videofluoroscopic Swallowing Study (VF)

Acute Stroke

OTHER

Adult inpatients in the acute stage post stroke who are referred for swallowing assessment.

Diagnostic Test: Videofluoroscopic Swallowing Study (VF)

Interventions

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.

Acute Stroke; Chronic Obstructive Pulmonary Disease; Healthy adults; Parkinson Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• University of Florida: collaborator
• McMaster University: collaborator
• National Institute on Aging (NIA): collaborator
• Ohio State University: collaborator
• University of Cincinnati: collaborator

Study Sites (5)

University of Florida

Gainesville, Florida, 32611, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45221, United States

Location

The Ohio State University

Columbus, Ohio, 43212, United States

Location

McMaster University

Hamilton, Ontario, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Catriona M Steele, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Emily K Plowman, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 11, 2022
• Study Start: November 15, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (2)