Screening in Oculopharyngeal Muscular Dystrophy

Completed

• Conditions: Oculopharyngeal Muscular Dystrophy
• Interventions: Procedure: Videofluoroscopic swallowing study; Other: Functional Oral Intake Scale; Other: Eating Assessment Tool-10

• Registration Number: NCT02877784
• Lead Sponsor: University of Florida

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:

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.

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 Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Study Start: 2016-10
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-25
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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).

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Exclusion Criteria

• Pregnant Women

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Screening	Eating Assessment Tool-10	Participants enrolled will undergo testing of the swallowing mechanism
Screening	Videofluoroscopic swallowing study	Participants enrolled will undergo testing of the swallowing mechanism
Screening	Functional Oral Intake Scale	Participants enrolled will undergo testing of the swallowing mechanism

Primary Outcome Measures

Name	Time	Method
Dynamic Imaging Grade of Swallowing Toxicity	Baseline	Global Metric of swallowing Safety and Efficiency

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States