Screening in Oculopharyngeal Muscular Dystrophy

Oculopharyngeal Muscular Dystrophy Clinical Trial

Official title:

Determination of Accurate Screening Tools for Dysphagia in Oculopharyngeal Muscular Dystrophy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877784
• Other study ID #: IRB201601374
• Status: Completed
• Start date: October 2016
• Est. completion date: August 2017

Study information

• Verified date: March 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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:

1. To identify accurate, reliable and non-invasive clinical markers of swallowing impairment

2. To determine the discriminate ability of these markers to identify impairments in swallow safety and swallowing efficiency.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy, Oculopharyngeal
• Oculopharyngeal Muscular Dystrophy

Intervention

Procedure:
• Videofluoroscopic swallowing study
Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.

Other:
• Functional Oral Intake Scale
The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.
• Eating Assessment Tool-10
The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic Imaging Grade of Swallowing Toxicity	Global Metric of swallowing Safety and Efficiency	Baseline
Secondary	Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)	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	Baseline
Secondary	Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)	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.	Baseline