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Physiological Flow of Liquids Used in Dysphagia Management

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ClinicalTrials.gov Identifier: NCT03192358
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : April 5, 2019
Sponsor:
Collaborators:
University of Florida
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.


Condition or disease Intervention/treatment
Amyotrophic Lateral Sclerosis Parkinson Disease Dysphagia Diagnostic Test: Videofluoroscopic Swallowing Examination Other: Tongue Strength Measurement

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Physiological Flow of Liquids Used in Dysphagia Management (Previously Tongue-Pressure Timing for Liquid Flow Detection and Control in Swallowing)
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 28, 2021


Group/Cohort Intervention/treatment
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.
Diagnostic Test: 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.

Other: 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).


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.
Diagnostic Test: 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.

Other: 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).





Primary Outcome Measures :
  1. Penetration-Aspiration Scale (Swallow Safety) [ Time Frame: Baseline (single timepoint) only ]
    The Penetration-Aspiration Scale (PAS) is an 8-point scale which will be used to characterize swallowing safety for each bolus trial. Levels 1 and 2 on the scale are considered safe, while levels >3 are considered unsafe.

  2. Normalized Residue Ratio Scale (Swallow Efficiency) [ Time Frame: Baseline (single timepoint) only ]
    The Normalized Residue Ratio Scale (NRRS) is a validated tool which will be used to quantify the amount of residue remaining in the throat after each swallow, in the vallecular and pyriform sinuses. NRRS values >0.07 (vallecular) and >0.2 (pyriform sinuses) are considered inefficient; NRRS values <0.07 (vallecular) and <0.2 (pyriform sinuses) are considered efficient.

  3. Number of Swallows per Bolus (Swallow Efficiency) [ Time Frame: Baseline (single timepoint) only ]
    The number of swallows needed to clear a single bolus will be counted. 1-2 swallows is considered efficient, while 3+ swallows for one bolus is considered inefficient.

  4. Pharyngeal Transit Duration (Bolus Flow) [ Time Frame: Baseline (single timepoint) only ]
    The time from bolus passing the ramus of the mandible (jaw) until it enters the upper esophageal sphincter will be calculated (in milliseconds), for each bolus. Pharyngeal transit duration <647ms is considered within normal limits, while pharyngeal transit duration >647ms is considered prolonged/impaired.

  5. Time to Laryngeal Vestibule Closure (Swallow Kinematics) [ Time Frame: Baseline (single timepoint) only ]
    The time from onset of hyoid movement until complete (or maximum approximation of) laryngeal vestibule closure will be calculated (in milliseconds), for each bolus. Time to laryngeal vestibule closure <121ms is considered within normal limits, while time to laryngeal vestibule closure >121ms is considered prolonged/impaired.

  6. Hyoid Bone Range of Movement (Swallow Kinematics) [ Time Frame: Baseline (single timepoint) only ]
    The maximum distance of the hyoid bone will be measured in normalized anatomical units, in reference to the cervical spine. Maximum distance of the hyoid bone >150% of the length of vertebrae C2-C4 is considered within functional limits, while maximum distance of the hyoid bone <150% of the C2-C4 vertebral length is considered impaired.

  7. Hyoid Speed/Velocity (Swallow Kinematics) [ Time Frame: Baseline (single timepoint) only ]
    The speed or velocity of hyoid movement will be calculated by dividing the distance of hyoid movement (in normalized anatomical units) by the duration (milliseconds).


Secondary Outcome Measures :
  1. Change in Anterior Maximum Tongue Pressure (IOPI) [ Time Frame: Baseline (single timepoint) only ]
    The Iowa Oral Performance Instrument (IOPI) will measure tongue strength (in kilopascals; kPa) while the participant presses with the front of their tongue. Measures of tongue strength will be taken once at the start and once end of the single data collection session; the change in pressure between these tasks will be used to explore endurance and fatigue.

  2. Change in Posterior Maximum Tongue Pressure (IOPI) [ Time Frame: Baseline (single timepoint) only ]
    The Iowa Oral Performance Instrument (IOPI) will measure tongue strength (in kilopascals; kPa) while the participant presses with the back of their tongue. Measures of tongue strength will be taken once at the start and once end of the single data collection session; the change in pressure between these tasks will be used to explore endurance and fatigue.

  3. Change in Saliva Swallow Tongue Pressure (IOPI) [ Time Frame: Baseline (single timepoint) only ]
    The Iowa Oral Performance Instrument (IOPI) will measure tongue strength (in kilopascals; kPa) while the participant swallows his or her saliva. Measures of tongue strength will be taken once at the start and once end of the single data collection session; the change in pressure between these tasks will be used to explore endurance and fatigue.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192358


Contacts
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Contact: Kelby Magennis, MPH 352-273-8632 kmagennis@phhp.ufl.edy
Contact: Ashley Waito, MSc 416-597-3422 ext 7812 ashley.waito@uhn.ca

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Emily K Plowman, PhD    352-273-9215    eplowman@phhp.ufl.edu   
Contact: Kelby Magennis, MPH    352-273-8632    kmagennis@phhp.ufl.edu   
Sponsors and Collaborators
University Health Network, Toronto
University of Florida
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Catriona M Steele, PhD University Health Network - Toronto Rehabilitation Institute
Principal Investigator: Emily K Plowman, PhD University of Florida

Publications:
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03192358     History of Changes
Other Study ID Numbers: DC011020
5R01DC011020-05 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Health Network, Toronto:
Thickened Liquids
Dysphagia Management
Videofluoroscopy
Swallowing Physiology

Additional relevant MeSH terms:
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Parkinson Disease
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Deglutition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neuromuscular Diseases
Spinal Cord Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases