Physiological Flow of Liquids Used in Dysphagia Management (Neuro)

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Amyotrophic Lateral Sclerosis Parkinson Disease Dysphagia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Amyotrophic Lateral Sclerosis

We will be recruiting individuals with confirmed or probably ALS, who experience speech or swallowing problems, to attend one data collection session. All participants will undergo the same protocol, including a Videofluoroscopic Swallowing Examination, and Tongue Strength Measurement.

Videofluoroscopic Swallowing Examination

Intervention Type DIAGNOSTIC_TEST

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.

Tongue Strength Measurement

Intervention Type OTHER

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).

Parkinson's Disease

We will be recruiting individuals with a diagnosis of Parkinson's disease, who experience speech or swallowing problems, to attend one data collection session. All participants will undergo the same protocol, including a Videofluoroscopic Swallowing Examination, and Tongue Strength Measurement.

Videofluoroscopic Swallowing Examination

Intervention Type DIAGNOSTIC_TEST

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.

Tongue Strength Measurement

Intervention Type OTHER

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).

Interventions

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Videofluoroscopic Swallowing Examination

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.

Intervention Type DIAGNOSTIC_TEST

Tongue Strength Measurement

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).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No