Clinical trial NCT02710162: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-03-16
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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).

Primary outcomes:
measure: The Penetration-aspiration scale will be used to measure swallowing function
timeFrame: Baseline
measure: The IOPI will be used to measure Lingual strength and endurance
timeFrame: Baseline
measure: The oral pneumatograph will be used to measure voluntary cough function
timeFrame: Baseline
measure: The nebulizer with cough protocol will be used to measure reflexive cough
timeFrame: Baseline
Secondary outcomes:
measure: Global disease progression as confirmed by the ALS Functional Rating Scale-Revised (ALSFRS-R)
timeFrame: Baseline
measure: Participant perception of swallowing impairment as confirmed by Swallowing Quality of Life Questionnaire (SWAL-QOL)
timeFrame: Baseline
measure: Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)
timeFrame: Baseline
measure: Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)
timeFrame: Baseline
measure: Participant perception of communication abilities as confirmed by Communication Effectiveness Survey
timeFrame: Baseline
measure: Bulbar function confirmed by the Center for Neurologic Studies Bulbar Function Scale (CNS-BFS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Emily Plowman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: