NCT04009408 · UNKNOWN
Expiratory Muscle Strength Training (EMST) in Neuromuscular Disorders
This study tests whether breathing out against resistance with a handheld device (EMST150) can improve swallowing, breathing, cough strength, eating, and quality of life in people with oculopharyngeal muscular dystrophy, a rare muscle disease. It has no phase label, which is common for device and exercise studies. It is not about Alzheimer's.
You may qualify if
- Diagnosis of oculopharyngeal muscular dystrophy (OPMD)
- 18 years of age or older
- Must be capable of providing informed consent
- Must be able to undergo respiratory function testing and swallowing studies
- Must have a forced vital capacity (FVC) greater than 60%
- A score of 3 or greater on the Eating Assessment Tool-10 (EAT-10; self-administered, symptom-specific outcome instrument for dysphagia. A score of 3 or greater indicates increased stress around eating)
- A score of 26 or greater on the Montreal Cognitive Assessment (MoCA; 30-point screening assessment used for detecting cognitive impairment. A score of 26 or greater is considered to be within functional limits.)
You're excluded if
- Severe coronary artery disease
- Acute myocardial infarction
- Moderate to severe hypovolemia
- Acute neurological events
- Unstable cardiac status
- Recent hernia
- Severe chronic obstructive pulmonary disease (COPD)
- Uncontrolled reflux issues
- Women who are pregnant, or who suspect they may be pregnant
- Cognitive impairment that would prevent comprehension of instructions and adherence to intervention guidelines (a score of less than 26 points on the MoCA)
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2022-04-21