Physiological Flow of Liquids Used in Dysphagia Management (Neuro)
Condition: Amyotrophic Lateral Sclerosis; Parkinson Disease; Dysphagia
MeSH terms: Deglutition Disorders; Parkinson Disease; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      This observational 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.
    

Intervention name(s): Videofluoroscopic Swallowing Examination; Tongue Strength Measurement
Intervention type(s): Diagnostic Test; Other
Intervention description(s): During the videofluoroscopy, subjects will take up to 21 sips of liquid, ranging in thickness from thin (like water), to extremely-thick (like pudding or custard). The liquids will be mixed with E-Z-Paque barium sulfate, to allow it to be visible on the x-ray.; We will measure tongue strength using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air will be placed in the mouth, just behind the front teeth. Participants will be asked to press their tongue upwards against the bulb as hard as they can, three (3) times at the front of the tongue and three (3) times at the back of the tongue (i.e., total of six (6) maximum isometric tongue presses). Participants will also be asked to swallow their saliva with the bulb placed in their mouth, three (3) times.
Tongue pressure measurement will be completed twice in the data collection session - once at the beginning, and once at the end (following the videofluoroscopy).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants with ALS will be recruited from the multidisciplinary ALS clinics at the
        University of Florida during regularly scheduled care visits. Participants with Parkinson's
        disease will be recruited from the University of Florida Center for Movement Disorders.
      
Keywords: Thickened Liquids; Dysphagia Management; Videofluoroscopy; Swallowing Physiology