Physiological Flow of Liquids Used in Dysphagia Management



Status:Recruiting
Conditions:Parkinsons Disease, Neurology, Neurology, Gastrointestinal
Therapuetic Areas:Gastroenterology, Neurology
Healthy:No
Age Range:18 - 90
Updated:4/6/2019
Start Date:November 1, 2017
End Date:February 28, 2021
Contact:Kelby Magennis, MPH
Email:kmagennis@phhp.ufl.edy
Phone:352-273-8632

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Physiological Flow of Liquids Used in Dysphagia Management (Previously Tongue-Pressure Timing for Liquid Flow Detection and Control in Swallowing)

For individuals with neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis and
Parkinson disease, swallowing impairment (i.e., dysphagia) is a common and serious symptom.
Dysphagia places the affected individual at risk for secondary health consequences, including
malnutrition and aspiration pneumonia, and negatively affects quality of life.

Thickened liquids are commonly recommended for individuals with dysphagia, as they flow more
slowly and reduce the risk of entry into the airway. However, there is limited understanding
about how changes in liquid thickness modulate swallowing physiology in individuals with
neurodegenerative conditions, and previous reports have shown that increased liquid thickness
may contribute to the accumulation of residue in the throat.

The purpose of this study is to explore swallowing physiology and function in individuals
with neurodegenerative conditions, across five levels of liquid thickness (thin,
slightly-thick, mildly-thick, moderately-thick, and extremely-thick), and to identify
boundaries of "optimal liquid thickness", which maintain airway safety, without contributing
to the accumulation of significant residue. Results from this study will help guide the
clinical recommendations for thickened liquids in dysphagia management.

This research study will measure swallowing function in individuals with Amyotrophic Lateral
Sclerosis or Parkinson's disease. The aims of this study are to (1) identify parameters of
swallowing physiology that are associated with impaired swallowing safety and efficiency, and
(2) explore how liquid thickness influences swallowing function.

Participation in this research study involves a single appointment at the University of
Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville. The
appointment will last approximately 1 hour, and will involve tasks to measure
tongue-strength, and a dynamic swallowing x-ray (known as videofluoroscopy) to evaluate
swallowing function. A selection of demographic information (e.g., age, onset of symptoms)
will also be recorded.

To measure tongue strength, participants will be given a disposable air-filled bulb and asked
to perform a series of tongue presses, and swallow their saliva. Next, during the
videofluoroscopy, participants will take sips of various liquids ranging in thickness from
thin (like water), to extremely-thick (similar to the consistency of pudding or yogurt). The
liquids will be mixed with a safe substance called barium, to make them visible on x-ray
images. After the videofluoroscopy has been completed, each participant will have their
tongue strength measured again, which will conclude their participation in the study.

Swallowing physiology will be measured from the videofluoroscopy images, post-hoc, by an
experienced team of blinded raters.

Inclusion Criteria:

- Adults (18+) with a confirmed diagnosis of Amyotrophic Lateral Sclerosis (ALS) or
Parkinson's disease (PD)

Exclusion Criteria:

- People with a prior medical history of stroke

- People with a prior medical history of acquired brain injury

- People with a prior medical history of spinal or spinal cord injury

- People with a prior medical history of cancer or surgery in the head and neck region

- People who have had radiation to the head and neck for cancer

- People who have a prior history of swallowing problems (e.g., from childhood, medical
complication)

- People with significant breathing difficulties (e.g., rely on mechanical ventilation)

- People who rely solely on tube-feeding for all meals and nutrition

- People who have Type I (insulin-dependent) Diabetes

- Women who are pregnant

- People who have allergies to barium, potato starch, corn starch, xanthan gum, milk
products, latex or dental glue
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Phone: 352-273-9215
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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