- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04773184
Improving Diagnostic Standards in Dysphagia
Improving Clinical and Instrumental Diagnostic Standards in Dysphagia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Amber Anderson, MS
- Phone Number: 352-427-6579
- Email: amber.anderson@phhp.ufl.edu
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Healthy Cohort:
132 individuals with no history of swallowing impairment or any health conditions known to impact swallowing function will be included in this study to serve as a comparative control group or reference standard group here and in future studies.
Disordered Cohort:
132 individuals with an underlying condition documented to lead to dysphagia will be enrolled in this study.
Description
Healthy Cohort:
132 individuals with no history of swallowing impairment or any health conditions known to impact swallowing function will be included in this study to serve as a comparative control group or reference standard group here and in future studies.
Inclusion criteria:
- Adults aged 18-90.
- No history of stroke, head and neck cancer or other disorder that might contribute to a swallowing impairment.
- No COVID-19 symptoms within the past 14 days, nor has been around someone testing positive for COVID-19 in the past 14 days.
- Not pregnant.
- No allergies to barium.
Exclusion criteria:
- Individuals under the age of 18 or over the age of 90.
- History of stroke, head and neck cancer or other disorder that might contribute to a swallowing impairment.
- Within the past 14 days, individuals with COVID-19 symptoms or a positive COVID-19 test, or who have been exposed to someone with confirmed COVID-19.
- Pregnant women.
- Individuals with allergies to barium.
Disordered Cohort:
132 individuals with an underlying condition documented to lead to dysphagia will be enrolled in this study.
Inclusion criteria:
- Adult participants aged between 18 and 90 years.
- Confirmed medical diagnosis associated with an increased risk of dysphagia including but are not limited to: head and neck cancer, neurologic (e.g., stroke, traumatic brain impairment), neurodegenerative (e.g., Parkinson's disease, amyotrophic lateral sclerosis), neuromuscular disorders (e.g., myotonic dystrophy, Pompe disease, inclusion body myositis) rheumatologic diseases (e.g., dermatomyositis, inclusion body myositis, scleroderma), chronic respiratory illnesses (e.g., chronic obstructive pulmonary disease), structural (e.g., mass or trauma to the upper aerodigestive tract) and iatrogenic conditions (e.g., post-surgical such as anterior cervical discectomy/fusion or cardiac, post-radiation treatment to the upper aerodigestive tract).
- No COVID-19 symptoms within the past 14 days, nor has been around someone testing positive for COVID-19 in the past 14 days.
- Not Pregnant.
- No allergies to barium.
Exclusion criteria:
- Individuals under the age of 18 or over the age of 90
- Within the past 14 days, individuals with COVID-19 symptoms or a positive COVID-19 test, or who have been exposed to someone with confirmed COVID-19.
- Pregnant women.
- Individuals with allergies to barium.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy adults
132 individuals with no history of swallowing impairment or any health conditions known to impact swallowing function will be included in this study to serve as a comparative control group or reference standard group here and in future studies.
|
This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
Other Names:
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing.
This is like a moving x-ray of the swallow.
Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.
The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.
The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol.
Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial.
This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.
Other Names:
Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) expressed as a percentage of predicted values.
Voicing tasks will be completed to assess vocal ability.
|
Adults at risk for swallowing impairment.
132 individuals with an underlying condition documented to lead to dysphagia will be enrolled in this study.
2) Confirmed medical diagnosis associated with an increased risk of dysphagia including but are not limited to: head and neck cancer, neurologic (e.g., stroke, traumatic brain impairment), neurodegenerative (e.g., Parkinson's disease, amyotrophic lateral sclerosis), neuromuscular disorders (e.g., myotonic dystrophy, Pompe disease, inclusion body myositis) rheumatologic diseases (e.g., dermatomyositis, inclusion body myositis, scleroderma), chronic respiratory illnesses (e.g., chronic obstructive pulmonary disease), structural (e.g., mass or trauma to the upper aerodigestive tract) and iatrogenic conditions (e.g., post-surgical such as anterior cervical discectomy/fusion or cardiac, post-radiation treatment to the upper aerodigestive tract).
|
This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
Other Names:
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing.
This is like a moving x-ray of the swallow.
Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.
The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.
The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol.
Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial.
This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.
Other Names:
Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) expressed as a percentage of predicted values.
Voicing tasks will be completed to assess vocal ability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Penetration Aspiration Scale
Time Frame: Baseline
|
Validated swallowing safety measurement that is an eight-point ordinal scale to indicate the depth of airway invasion during swallowing and the associated response.
A minimum score of 1 would be no airway invasion, to a maximum score of 8 being airway invasion with no effort to expel the tracheal matter.
Therefore, the lower the score, the better the outcome.
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Baseline
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Yale Residue Severity Rating Scale
Time Frame: Baseline
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Validated measure of swallowing efficiency using a validated anatomically defined and image-based assessment of post-swallow pharyngeal residue severity.
Clinical uses include accurate classification of vallecula and pyriform sinus residue severity patterns as none, trace, mild, moderate, or severe for diagnostic purposes, determination of functional therapeutic change, and precise dissemination of shared information.
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Baseline
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Vocal Fold Mobility Impairment
Time Frame: Baseline
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During a Fiberoptic Endoscopic Evaluation of Swallowing (FEES), the vocal folds will be visualized using a small camera passed through the open nasal passage.
The patient will be asked to make a series of vocal tasks so that we can visualize their movement, any immobility will be notated.
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Baseline
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Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
Time Frame: Baseline
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5-point ordinal scale used to rate both the safety and efficiency of swallowing trials.
For efficiency, the minimal score of 0 means residue is less than 10%, the maximal score of 4 means there is more than 90% of residue across trials.
For safety a minimal score of 0 means no airway invasion, and a maximal score of 4 means there was chronic and gross amounts of food or liquids that were aspirated.
Therefore, the lower the scores, the better the outcomes.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily Plowman, PhD, University of Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202003199
- OCR40105 (Other Identifier: UF OnCore)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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