Reference Values for Videofluoroscopic Measures of Swallowing

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University Health Network, Toronto
Study ID
NCT05497219
Status
Enrolling By Invitation

Conditions

  • Dysphagia, Oropharyngeal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Nov 15, 2022
Status verified
Sep 2025
Primary completion
Nov 30, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
580 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Healthy adults
    Adults aged 18 or older with no history of swallowing impairment
  • Other: Parkinson Disease
    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.
  • Other: Chronic Obstructive Pulmonary Disease
    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.
  • Other: Acute Stroke
    Adult inpatients in the acute stage post stroke who are referred for swallowing assessment.

Primary Outcome Measure

Number of participants with unsafe swallowing [ Time Frame: Baseline ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611-
University of Cincinnati Medical CenterCincinnatiOhio45221-
The Ohio State UniversityColumbusOhio43212-

Find similar trials in Gainesville, FL

By research site
University of Florida· Gainesville, FLUniversity of Cincinnati Medical Center· Cincinnati, OHThe Ohio State University· Columbus, OH

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