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Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Micro Mouth Pressure Meter
Iowa Oral Performance Instrument
Electrical Impedance Myography
Capsaicin
Videofluoroscopic Swallowing Study
Pulmonary Function Testing
Swallowing Related Quality of Life Questionnaire
Functional Oral Intake Scale
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised
Eating Assessment Tool-10
Communicative Effectiveness Survey
The Center for Neurologic Studies Bulbar Function Scale
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of probable or definite ALS

Exclusion Criteria:

  • allergies to barium or capsaicin
  • tracheotomy or mechanical ventilation
  • absence of diaphragmatic pacer
  • respiratory disease (COPD).

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Screening

Arm Description

Participants enrolled will have the following test: Micro Mouth Pressure Meter, reflexive cough testing (with capsaicin used in blocks), lingual strength and endurance trials using the Iowa Oral Performance Instrument, Electrical Impedance Myography of the tongue, Pulmonary Function Testing, and a Videofluoroscopic Swallowing Study. In addition, the patient will complete the following surveys: Swallowing Related Quality of Life Questionnaire (SWAL-QOL), Eating Assessment Tool-10 (EAT-10), Functional Oral Intake Scale (FOIS), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS), and the Communicative Effectiveness Survey (CES).

Outcomes

Primary Outcome Measures

The Penetration-aspiration scale will be used to measure swallowing function
The IOPI will be used to measure Lingual strength and endurance
The Iowa Oral Pressure Instrument device will measure the peak performance of lingual strength a via the action of a bulb placed on the hard palate. To assess maximum anterior isometric pressure, the bulb will be placed on the roof of the mouth and the participant will raise his or her tongue to apply pressure to this bulb and then quickly release the tongue back into a neutral position. This repetitive tongue movement will be performed three times and values will be recorded.
The oral pneumatograph will be used to measure voluntary cough function
Voluntary cough function will be assessed using an oral pneumotachograph, connected to a spirometer filter during voluntary cough production. The participant will be seated with a respiratory face-mask held in place by the examiner and instructed to complete three tidal breaths into the face-mask, airflow signal will be measured
The nebulizer with cough protocol will be used to measure reflexive cough
Reflexive cough will be assessed using an oral pneumotachograph, differential pressure transducer, and have a side port with a one-way inspiratory valve for nebulizer connection. The nebulizer will deliver three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.

Secondary Outcome Measures

Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R)
The ALSFRS-R includes 12 questions. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 48=best.
Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL)
SWAL-QOL is a standardized psychometric scale measuring swallow-related QOL and containing 44-items relating to swallowing specific quality of life measured across 10 domains. Individual domain scores and a total SWAL-QOL score will be derived. Scores range from 0 to 100, with a score of 100 representing no impairment (the most favorable state)
Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)
FOIS is a validated 7-point scale indexing an individual's ability to intake food on a day-to-day basis. TUBE DEPENDENT (levels 1-3) No oral intake Tube dependent with minimal/inconsistent oral intake Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) Total oral intake of a single consistency Total oral intake of multiple consistencies requiring special preparation Total oral intake with no special preparation, but must avoid specific foods or liquid items Total oral intake with no restrictions
Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)
EAT-10 is a 10-item validated self-administered dysphagia severity symptom survey. Score is 0 - 40 with 0 being the best possible score and 40 the worst possible score.
Participant perception of communication abilities as confirmed by Communication Effectiveness Survey
A measure of self-rated communication abilities across a variety of settings as perceived by the patients and/or their caregivers will be measured using the 8-point Communication Effectiveness Survey (CES)
Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS)

Full Information

First Posted
February 29, 2016
Last Updated
December 19, 2017
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02710162
Brief Title
Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)
Official Title
Determination of Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
December 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Individuals with th Amyotrophic Lateral Sclerosis are at high risk for swallowing impairment (dysphagia) which leads to malnutrition, decreased pulmonary health, aspiration and aspiration pneumonia. These sequelae necessitate timely identification of at risk individuals to ensure optimal management of oral intake and pulmonary function. The purpose of this study is to evaluate the discriminant ability of several non-invasive screening tools at detecting swallowing impairment in individuals with ALS.
Detailed Description
This research study is being performed to determine how accurate different screening tools or tests are at identifying swallowing problems associated with Amyotrophic Lateral Sclerosis (ALS). As a participant one evaluation will be performed at the University of Florida Swallowing Systems Core laboratory located at Shands Hospital, Gainesville will take place. This will take approximately two-hours. During this evaluation an videofluoroscopy (X-ray of swallowing), cough tests, tongue function test and questionnaires will be completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screening
Arm Type
Experimental
Arm Description
Participants enrolled will have the following test: Micro Mouth Pressure Meter, reflexive cough testing (with capsaicin used in blocks), lingual strength and endurance trials using the Iowa Oral Performance Instrument, Electrical Impedance Myography of the tongue, Pulmonary Function Testing, and a Videofluoroscopic Swallowing Study. In addition, the patient will complete the following surveys: Swallowing Related Quality of Life Questionnaire (SWAL-QOL), Eating Assessment Tool-10 (EAT-10), Functional Oral Intake Scale (FOIS), Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R), The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS), and the Communicative Effectiveness Survey (CES).
Intervention Type
Device
Intervention Name(s)
Micro Mouth Pressure Meter
Other Intervention Name(s)
digital manometer, Micro medical device
Intervention Description
The participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flanged rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) used.
Intervention Type
Device
Intervention Name(s)
Iowa Oral Performance Instrument
Other Intervention Name(s)
IOPI
Intervention Description
The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
Intervention Type
Device
Intervention Name(s)
Electrical Impedance Myography
Other Intervention Name(s)
EIM
Intervention Description
The SFB7 Bioimpedance device measures the function of the tongue by calculating measures of reactance, resistance and phase once a custom electrode array is placed on the midline of the subject's tongue for approximately 2 seconds.
Intervention Type
Drug
Intervention Name(s)
Capsaicin
Other Intervention Name(s)
Hot pepper
Intervention Description
A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction "cough if you need to" prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds.
Intervention Type
Procedure
Intervention Name(s)
Videofluoroscopic Swallowing Study
Other Intervention Name(s)
VFSS, modified barium swallow (MBS), X-Ray of swallowing
Intervention Description
Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
Intervention Type
Procedure
Intervention Name(s)
Pulmonary Function Testing
Intervention Description
Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values.
Intervention Type
Other
Intervention Name(s)
Swallowing Related Quality of Life Questionnaire
Other Intervention Name(s)
SWAL-QOL
Intervention Description
Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.
Intervention Type
Other
Intervention Name(s)
Functional Oral Intake Scale
Other Intervention Name(s)
FOIS
Intervention Description
The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.
Intervention Type
Other
Intervention Name(s)
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised
Other Intervention Name(s)
ALSFRS-R
Intervention Description
The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to track global disease progression in participants.
Intervention Type
Other
Intervention Name(s)
Eating Assessment Tool-10
Other Intervention Name(s)
EAT-10
Intervention Description
The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
Intervention Type
Other
Intervention Name(s)
Communicative Effectiveness Survey
Other Intervention Name(s)
CES
Intervention Description
The Communication Effectiveness Survey (CES) will be used for participant reporting of communication abilities across different speech contexts.
Intervention Type
Other
Intervention Name(s)
The Center for Neurologic Studies Bulbar Function Scale
Other Intervention Name(s)
CNS-BFS
Intervention Description
The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.
Primary Outcome Measure Information:
Title
The Penetration-aspiration scale will be used to measure swallowing function
Time Frame
Baseline
Title
The IOPI will be used to measure Lingual strength and endurance
Description
The Iowa Oral Pressure Instrument device will measure the peak performance of lingual strength a via the action of a bulb placed on the hard palate. To assess maximum anterior isometric pressure, the bulb will be placed on the roof of the mouth and the participant will raise his or her tongue to apply pressure to this bulb and then quickly release the tongue back into a neutral position. This repetitive tongue movement will be performed three times and values will be recorded.
Time Frame
Baseline
Title
The oral pneumatograph will be used to measure voluntary cough function
Description
Voluntary cough function will be assessed using an oral pneumotachograph, connected to a spirometer filter during voluntary cough production. The participant will be seated with a respiratory face-mask held in place by the examiner and instructed to complete three tidal breaths into the face-mask, airflow signal will be measured
Time Frame
Baseline
Title
The nebulizer with cough protocol will be used to measure reflexive cough
Description
Reflexive cough will be assessed using an oral pneumotachograph, differential pressure transducer, and have a side port with a one-way inspiratory valve for nebulizer connection. The nebulizer will deliver three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R)
Description
The ALSFRS-R includes 12 questions. Each task is rated on a five-point scale from 0 = can't do, to 4 = normal ability. Individual item scores are summed to produce a reported score of between 0=worst and 48=best.
Time Frame
Baseline
Title
Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL)
Description
SWAL-QOL is a standardized psychometric scale measuring swallow-related QOL and containing 44-items relating to swallowing specific quality of life measured across 10 domains. Individual domain scores and a total SWAL-QOL score will be derived. Scores range from 0 to 100, with a score of 100 representing no impairment (the most favorable state)
Time Frame
Baseline
Title
Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)
Description
FOIS is a validated 7-point scale indexing an individual's ability to intake food on a day-to-day basis. TUBE DEPENDENT (levels 1-3) No oral intake Tube dependent with minimal/inconsistent oral intake Tube supplements with consistent oral intake TOTAL ORAL INTAKE (levels 4-7) Total oral intake of a single consistency Total oral intake of multiple consistencies requiring special preparation Total oral intake with no special preparation, but must avoid specific foods or liquid items Total oral intake with no restrictions
Time Frame
Baseline
Title
Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)
Description
EAT-10 is a 10-item validated self-administered dysphagia severity symptom survey. Score is 0 - 40 with 0 being the best possible score and 40 the worst possible score.
Time Frame
Baseline
Title
Participant perception of communication abilities as confirmed by Communication Effectiveness Survey
Description
A measure of self-rated communication abilities across a variety of settings as perceived by the patients and/or their caregivers will be measured using the 8-point Communication Effectiveness Survey (CES)
Time Frame
Baseline
Title
Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of probable or definite ALS Exclusion Criteria: allergies to barium or capsaicin tracheotomy or mechanical ventilation absence of diaphragmatic pacer respiratory disease (COPD).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Plowman, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Accurate Screening Tools for Dysphagia in Amyotrophic Lateral Sclerosis (ALS)

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