Clinical trial NCT04773184: Improving Diagnostic Standards in Dysphagia
Official title: Improving Clinical and Instrumental Diagnostic Standards in Dysphagia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphagia
Keywords: Dysphagia
Peak Cough Flow (PCF)
Swallowing
Respiration
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: 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:

1. Adults aged 18-90.
2. No history of stroke, head and neck cancer or other disorder that might contribute to a swallowing impairment.
3. No COVID-19 symptoms within the past 14 days, nor has been around someone testing positive for COVID-19 in the past 14 days.
4. Not pregnant.
5. No allergies to barium.

Exclusion criteria:

1. Individuals under the age of 18 or over the age of 90.
2. History of stroke, head and neck cancer or other disorder that might contribute to a swallowing impairment.
3. 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.
4. Pregnant women.
5. 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:

1. Adult participants aged between 18 and 90 years.
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).
3. No COVID-19 symptoms within the past 14 days, nor has been around someone testing positive for COVID-19 in the past 14 days.
4. Not Pregnant.
5. No allergies to barium.

Exclusion criteria:

1. Individuals under the age of 18 or over the age of 90
2. 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.
3. Pregnant women.
4. Individuals with allergies to barium.

Primary outcomes:
measure: Penetration Aspiration Scale
timeFrame: Baseline
measure: Yale Residue Severity Rating Scale
timeFrame: Baseline
measure: Vocal Fold Mobility Impairment
timeFrame: Baseline
measure: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Health
state: Florida
Study officials:
affiliation: University of Florida
name: Emily Plowman, PhD
role: PRINCIPAL_INVESTIGATOR
References: