DysphagiaNCT04773184
Improving Diagnostic Standards in Dysphagia
An observational study of Dysphagia, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysphagia
- What is being tested?
- Fiberoptic Endoscopic Evaluation of Swallowing, Videofluoroscopic Swallowing Study and Voluntary Peak Cough Flow Testing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 23 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- Adult participants aged between 18 and 90 years.
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- 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.
Who cannot join
- 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:
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- 132 individuals with an underlying condition documented to lead to dysphagia will be enrolled in this study.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Health
Gainesville, Florida, 32610
About this study
Official title: Improving Clinical and Instrumental Diagnostic Standards in Dysphagia.
The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing problem. Our goal is to identify the best tests that can be quickly and easily administered to accurately detect swallowing impairment in adults. Involvement is limited to a single 2-hour evaluation.
Read the detailed description
The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. It will take approximately 90-120 minutes to complete. During this examination, you will have respiratory testing, cough testing, lingual testing, voice testing, and will be asked to fill out some surveys. We will then complete the swallowing test that uses both a moving x-ray and a small camera will be inserted into the open passage of your nose to the back of your throat to watch your swallow and look at your vocal folds (voice box). This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing problem. Our goal is to identify the best tests that can be quickly and easily administered to accurately detect swallowing impairment in adults. Your involvement is limited to a single 2-hour evaluation.
- Conditions
- Dysphagia
- Being tested
- Fiberoptic Endoscopic Evaluation of Swallowing, Videofluoroscopic Swallowing Study, Voluntary Peak Cough Flow Testing, Iowa Oral Performance Instrument, Capsaicin Challenge
- Keywords
- Dysphagia, Peak Cough Flow (PCF), Swallowing, Respiration
- Medical subject headings
- Deglutition Disorders, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fiberoptic Endoscopic Evaluation of SwallowingProcedure or surgery
Also called (FEES)
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.
Videofluoroscopic Swallowing StudyProcedure or surgery
Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing. This is like a moving x-ray of the swallow.
Voluntary Peak Cough Flow TestingProcedure or surgery
Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.
Iowa Oral Performance InstrumentProcedure or surgery
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.
Capsaicin ChallengeProcedure or surgery
Also called Reflexive Cough Testing
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.
Pulmonary Function TestingProcedure or surgery
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 TasksOther
Voicing tasks will be completed to assess vocal ability.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Fiberoptic Endoscopic Evaluation of Swallowing; Procedure: Videofluoroscopic Swallowing Study; Procedure: Voluntary Peak Cough Flow Testing; Procedure: Iowa Oral Performance Instrument; Procedure: Capsaicin Challenge; Procedure: Pulmonary Function Testing; Other: Voicing Tasks | |
| 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). Receives: Procedure: Fiberoptic Endoscopic Evaluation of Swallowing; Procedure: Videofluoroscopic Swallowing Study; Procedure: Voluntary Peak Cough Flow Testing; Procedure: Iowa Oral Performance Instrument; Procedure: Capsaicin Challenge; Procedure: Pulmonary Function Testing; Other: Voicing Tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration Aspiration Scale
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.
Measured: Baseline
Yale Residue Severity Rating Scale
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.
Measured: Baseline
Vocal Fold Mobility Impairment
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.
Measured: Baseline
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start27 Apr 2021
- Primary completion23 Sep 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Plowman, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773184
- Sponsor's protocol ID
- IRB202003199
- Other IDs
- OCR40105
- Status last verified
- Jan 2024
- First submitted
- 23 Feb 2021
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None at this time
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Clinical and Instrumental Diagnostic Standards in Dysphagia.
- ClinicalTrials.gov ID
- NCT04773184
- Acronym / sponsor ID
- IRB202003199
- Conditions
- Dysphagia
- Keywords
- Dysphagia, Peak Cough Flow (PCF), Swallowing, Respiration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 23 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 26 Feb 2021 (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.
The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing problem. Our goal is to identify the best tests that can be quickly and easily administered to accurately detect swallowing impairment in adults. Involvement is limited to a single 2-hour evaluation.
Detailed description
The purpose of this research is to understand the normal function of swallowing and respiratory muscles in order to establish normal parameters. It will take approximately 90-120 minutes to complete. During this examination, you will have respiratory testing, cough testing, lingual testing, voice testing, and will be asked to fill out some surveys. We will then complete the swallowing test that uses both a moving x-ray and a small camera will be inserted into the open passage of your nose to the back of your throat to watch your swallow and look at your vocal folds (voice box). This will allow us to compare normal physiology and function of swallowing and breathing muscles to people with a medical history that would put them at risk for a swallowing problem. Our goal is to identify the best tests that can be quickly and easily administered to accurately detect swallowing impairment in adults. Your involvement is limited to a single 2-hour evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Procedure: Fiberoptic Endoscopic Evaluation of Swallowing, Procedure: Videofluoroscopic Swallowing Study, Procedure: Voluntary Peak Cough Flow Testing, Procedure: Iowa Oral Performance Instrument, Procedure: Capsaicin Challenge, Procedure: Pulmonary Function Testing, Other: Voicing Tasks132 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. |
| Adults at risk for swallowing impairment. | – | Procedure: Fiberoptic Endoscopic Evaluation of Swallowing, Procedure: Videofluoroscopic Swallowing Study, Procedure: Voluntary Peak Cough Flow Testing, Procedure: Iowa Oral Performance Instrument, Procedure: Capsaicin Challenge, Procedure: Pulmonary Function Testing, Other: Voicing Tasks132 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). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Fiberoptic Endoscopic Evaluation of SwallowingAlso: (FEES)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. | Procedure or surgery | Adults at risk for swallowing impairment., Healthy adults |
| Videofluoroscopic Swallowing StudyVideofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing. This is like a moving x-ray of the swallow. | Procedure or surgery | Adults at risk for swallowing impairment., Healthy adults |
| Voluntary Peak Cough Flow TestingVoluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing. | Procedure or surgery | Adults at risk for swallowing impairment., Healthy adults |
| Iowa Oral Performance InstrumentThe 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. | Procedure or surgery | Adults at risk for swallowing impairment., Healthy adults |
| Capsaicin ChallengeAlso: Reflexive Cough TestingA 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. | Procedure or surgery | Adults at risk for swallowing impairment., Healthy adults |
| Pulmonary Function TestingPulmonary 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. | Procedure or surgery | Adults at risk for swallowing impairment., Healthy adults |
| Voicing TasksVoicing tasks will be completed to assess vocal ability. | Other | Adults at risk for swallowing impairment., Healthy adults |
Primary outcome
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.
Yale Residue Severity Rating Scale
Time frame: Baseline
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.
Vocal Fold Mobility Impairment
Time frame: Baseline
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.
Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
Time frame: Baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No. None at this time
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Dysphagia
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. This study is not recruiting at the moment.
Emily Plowman, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by University of Florida at 1 site in United States.
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 10 inclusion and 11 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: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Penetration Aspiration Scale (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?
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 17 Jan 2024; AzTrials last refreshed its copy on 30 Oct 2026.