Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Device, Drug, Procedure, N/A
Intervention Name:
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
Placebo:
Phase:
Phase 1
Study Chair(s)/Principal Investigator(s):
Emily Plowman, Ph.D., University of Florida
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
University of Florida
Gainesville, Florida, 32605 United States
Full Study Summary:
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.
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.
Study Sponsor:
University of Florida
Estimated Enrollment:
21
Estimated Study Start Date:
02 / 29 / 2016
Estimated Study Completion Date:
12 / 19 / 2017
Posting Last Modified Date:
12 / 21 / 2017
Date Study Added to neals.org:
03 / 16 / 2016
Minimum Age:
21 Years
Maximum Age:
85 Years
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).
University of Florida
Gainesville, Florida
32605
United States