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OpenTrials
Completed

NCT Number: NCT02877784

Screening in Oculopharyngeal Muscular Dystrophy

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.

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Key information

Conditions

Oculopharyngeal Muscular Dystrophy Articulation Disorders Communication Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Deglutition Disorders Digestive System Diseases Dysarthria Esophageal Diseases Gastrointestinal Diseases Genetic Diseases, Inborn Language Disorders Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Oculopharyngeal Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Speech Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Videofluoroscopic Swallowing Study

Procedure

Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.

Other names: VFSS, modified barium swallow (MBS)

Functional Oral Intake Scale

Other

The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.

Other names: FOIS

Eating Assessment Tool-10

Other

The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.

Other names: EAT-10

Primary outcomes

  1. Dynamic Imaging Grade of Swallowing Toxicity

    Time frame: Baseline

    Global Metric of swallowing Safety and Efficiency

Secondary outcomes

  1. Dietary intake as confirmed by Functional Oral Intake Scale (FOIS)

    Time frame: 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

  2. Participant perception of swallowing related symptoms as confirmed by The Eating Assessment Tool 10 (EAT-10)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Determination of Accurate Screening Tools for Dysphagia in Oculopharyngeal Muscular Dystrophy

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 24, 2016
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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