Screening in Oculopharyngeal Muscular Dystrophy
Study Details
Study Description
Brief Summary
Oculopharyngeal muscular dystrophy (OPMD) is a rare myopathic disease that results in progressive degeneration of the oral and pharyngeal muscular, resulting in severe dysphagia and dysarthria. OPMD is considered a rare disease; therefore, limited research is available on the natural progression of the disease or the utility of biomarkers to identify swallowing impairment. The aim of this study is:
-
To identify accurate, reliable and non-invasive clinical markers of swallowing impairment
-
To determine the discriminate ability of these markers to identify impairments in swallow safety and swallowing efficiency.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Participants will be recruited from the Neurology clinic at the University of Florida. The single evaluation will occur in the PIs research laboratory at the University of Florida, Gainesville, Florida.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Screening Participants enrolled will undergo testing of the swallowing mechanism |
Procedure: Videofluoroscopic swallowing study
Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
Other Names:
Other: Functional Oral Intake Scale
The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.
Other Names:
Other: Eating Assessment Tool-10
The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Dynamic Imaging Grade of Swallowing Toxicity [Baseline]
Global Metric of swallowing Safety and Efficiency
Secondary Outcome Measures
- Dietary intake as confirmed by Functional Oral Intake Scale (FOIS) [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
- Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10) [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida | Gainesville | Florida | United States | 32610 |
Sponsors and Collaborators
- University of Florida
Investigators
- Principal Investigator: Emily Plowman, PhD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB201601374