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Completed

NCT Number: NCT02710162

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Florida

Gainesville, Florida, 32605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Micro Mouth Pressure Meter

Device

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.

Other names: digital manometer, Micro medical device

IOWA ORAL PERFORMANCE INSTRUMENT

Device

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.

Other names: IOPI

Electrical Impedance Myography

Device

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.

Other names: EIM

Capsaicin

Drug

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.

Other names: Hot pepper

Videofluoroscopic Swallowing Study

Procedure

Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.

Other names: VFSS, modified barium swallow (MBS), X-Ray of swallowing

Pulmonary Function Testing

Procedure

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.

Swallowing Related Quality of Life Questionnaire

Other

Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.

Other names: SWAL-QOL

Functional Oral Intake Scale

Other

The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.

Other names: FOIS

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised

Other

The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to track global disease progression in participants.

Other names: ALSFRS-R

Eating Assessment Tool-10

Other

The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.

Other names: EAT-10

Communicative Effectiveness Survey

Other

The Communication Effectiveness Survey (CES) will be used for participant reporting of communication abilities across different speech contexts.

Other names: CES

The Center for Neurologic Studies Bulbar Function Scale

Other

The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.

Other names: CNS-BFS

Primary outcomes

  1. The Penetration-aspiration scale will be used to measure swallowing function

    Time frame: Baseline

  2. The IOPI will be used to measure Lingual strength and endurance

    Time frame: Baseline

    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.

  3. The oral pneumatograph will be used to measure voluntary cough function

    Time frame: Baseline

    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

  4. The nebulizer with cough protocol will be used to measure reflexive cough

    Time frame: Baseline

    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 outcomes

  1. Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R)

    Time frame: Baseline

    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.

  2. Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL)

    Time frame: Baseline

    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)

  3. Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)

    Time frame: Baseline

    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

  4. Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)

    Time frame: Baseline

    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.

  5. Participant perception of communication abilities as confirmed by Communication Effectiveness Survey

    Time frame: Baseline

    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)

  6. Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2016
Registry last updated
Dec 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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