|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02877784 |
|
Date of registration:
|
19/08/2016 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Screening in Oculopharyngeal Muscular Dystrophy
|
|
Scientific title:
|
Determination of Accurate Screening Tools for Dysphagia in Oculopharyngeal Muscular Dystrophy |
|
Date of first enrolment:
|
October 2016 |
|
Target sample size:
|
8 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02877784 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Emily Plowman, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Florida |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- diagnosis of oculopharyngeal muscular dystrophy
- no allergies to barium or capsaicin,
- no tracheotomy or mechanical ventilation
- no significant concurrent respiratory disease (e.g., COPD).
Exclusion Criteria:
- Pregnant Women
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Oculopharyngeal Muscular Dystrophy
|
|
Intervention(s)
|
|
Other: Eating Assessment Tool-10
|
|
Procedure: Videofluoroscopic swallowing study
|
|
Other: Functional Oral Intake Scale
|
|
Primary Outcome(s)
|
|
Dynamic Imaging Grade of Swallowing Toxicity
[Time Frame: Baseline]
|
|
Secondary Outcome(s)
|
|
Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)
[Time Frame: Baseline]
|
|
Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)
[Time Frame: Baseline]
|
|
Secondary ID(s)
|
|
IRB201601374
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|