Improving Diagnostic Standards in Dysphagia

University of Florida

Status: Completed

Conditions: Dysphagia

Treatments: Procedure: Pulmonary Function Testing; Procedure: Capsaicin Challenge; Procedure: Voluntary Peak Cough Flow Testing; Procedure: Iowa Oral Performance Instrument; Procedure: Fiberoptic Endoscopic Evaluation of Swallowing; Other: Voicing Tasks; Procedure: Videofluoroscopic Swallowing Study

Study type: Observational

Funder types: Other

Identifiers

NCT04773184

OCR40105 (Other Identifier)

IRB202003199

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

46 participants in 2 patient groups

Healthy adults

Description:

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.

Treatment:

Procedure: Iowa Oral Performance Instrument

Procedure: Voluntary Peak Cough Flow Testing

Procedure: Pulmonary Function Testing

Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

Procedure: Videofluoroscopic Swallowing Study

Procedure: Capsaicin Challenge

Other: Voicing Tasks

Adults at risk for swallowing impairment.

Description:

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).

Treatment:

Procedure: Iowa Oral Performance Instrument

Procedure: Voluntary Peak Cough Flow Testing

Procedure: Pulmonary Function Testing

Procedure: Fiberoptic Endoscopic Evaluation of Swallowing

Procedure: Videofluoroscopic Swallowing Study

Procedure: Capsaicin Challenge

Other: Voicing Tasks