- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05497219
Reference Values for Videofluoroscopic Measures of Swallowing (NIA_RV)
Establishing Reference Values and Clinical Decision Points for Quantitative Videofluoroscopic Measures of Swallowing
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada
- McMaster University
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
-
-
-
Florida
-
Gainesville, Florida, United States, 32611
- University of Florida
-
-
Ohio
-
Cincinnati, Ohio, United States, 45221
- University of Cincinnati Medical Center
-
Columbus, Ohio, United States, 43212
- The Ohio State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
- Healthy volunteers will be recruited broadly from the local populations of the study data collection sites (Toronto, Canada; Hamilton, Canada; Gainesville, Canada).
- Participants in the clinical cohorts will be referred by physicians at the participating institutions based on the study inclusion criteria (diagnostic confirmation of either Parkinson Disease, Chronic Obstructive Pulmonary Disease, recent hospitalization involving intensive care and mechanical ventilation for > 48 hrs, or recent cardiac surgery).
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy adults
Adults aged 18 or older with no history of swallowing impairment
|
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.
|
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.
|
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.
|
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.
|
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.
|
Other: Acute Stroke
Adult inpatients in the acute stage post stroke who are referred for swallowing assessment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Baseline
|
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).
|
Baseline
|
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).
|
Baseline
|
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.
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Catriona M Steele, PhD, University Health Network, Toronto
- Principal Investigator: Emily K Plowman, PhD, Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-6019
- R01AG077481 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dysphagia, Oropharyngeal
-
Peter Belafsky, MDTerminatedDysphagia | Oropharyngeal Dysphagia (OPD)United States
-
Morinaga Milk Industry Co., LTDHospital de MataróRecruitingDysphagia | Swallowing Disorder | Dysphagia, Oral Phase | Dysphagia, Esophageal | Dysphagia, OropharyngealSpain
-
Sheffield Teaching Hospitals NHS Foundation TrustUniversity of CambridgeCompletedDysphagia, OropharyngealUnited Kingdom
-
Complexo Hospitalario Universitario de A CoruñaCompleted
-
Hvidovre University HospitalRecruitingDeglutition Disorders | Dysphagia, OropharyngealDenmark
-
Peter Belafsky, MDCook MyoSiteRecruitingOropharyngeal DysphagiaUnited States
-
Region Örebro CountyUnknownDysphagia | Oropharyngeal Dysphagia
-
University of California, DavisCalifornia Institute for Regenerative Medicine (CIRM); Cook MyoSiteRecruitingOropharyngeal DysphagiaUnited States
-
All India Institute of Medical Sciences, New DelhiRecruitingOropharyngeal Dysphagia | Dysphagia, Late Effect of Stroke | Transfer Dysphagia | Cricopharyngeus Muscle DysfunctionIndia
-
Hospital de MataróCompletedDysphagia | Oropharyngeal Dysphagia | Swallowing DisorderSpain
Clinical Trials on Videofluoroscopic Swallowing Study (VF)
-
University Health Network, TorontoUniversity of Florida; McMaster University; National Institute on Deafness and...Completed
-
University Health Network, TorontoCanadian Institutes of Health Research (CIHR)Completed
-
University Health Network, TorontoUniversity of Florida; National Institute on Deafness and Other Communication...CompletedParkinson Disease | Amyotrophic Lateral Sclerosis | DysphagiaUnited States
-
University of FloridaCompleted
-
Bezmialem Vakif UniversityCompletedStroke | Dysphagia, OropharyngealTurkey
-
Milton S. Hershey Medical CenterPenn State University; Congressionally Directed Medical Research ProgramsRecruiting
-
University of FloridaCompleted
-
University of Wisconsin, MadisonGordon and Betty Moore FoundationCompleted
-
University of FloridaALS AssociationCompletedAmyotrophic Lateral SclerosisUnited States
-
University of FloridaNational Institute of Neurological Disorders and Stroke (NINDS)Completed