Status:
COMPLETED
Improving Diagnostic Standards in Dysphagia
Lead Sponsor:
University of Florida
Conditions:
Dysphagia
Eligibility:
All Genders
18-90 years
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 fun...
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. ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 23 2023
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04773184
Start Date
April 27 2021
End Date
September 23 2023
Last Update
January 17 2024
Active Locations (1)
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1
University of Florida Health
Gainesville, Florida, United States, 32610