Expiratory muscle strength therapy (EMST150, Aspire LLC) for Muscular Dystrophies

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neuromuscular Clinic, South Health Campus, Calgary, Canada
Muscular Dystrophies+5 More
Expiratory muscle strength therapy (EMST150, Aspire LLC) - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Expiratory Muscle Strength Training (EMST) in Neuromuscular Disorders

See full description

Eligible Conditions

  • Muscular Dystrophies
  • Muscular Dystrophy, Oculopharyngeal (OPMD)
  • Myopathy; Hereditary

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Expiratory muscle strength therapy (EMST150, Aspire LLC) will improve 7 secondary outcomes in patients with Muscular Dystrophies. Measurement will happen over the course of Baseline measurement (week 0).

Baseline measurement (week 0)
Biomarker analyses
Week 15
Global Swallowing Function
Week 15
Forced vital capacity (FVC)
Maximum expiratory pressure (MEP)
Oral Intake
Self-perceived swallowing impairment
Volitional cough strength (peak cough flow)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

EMST therapy
1 of 2
Sham EMST therapy
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Expiratory Muscle Strength Therapy (EMST150, Aspire LLC) is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

EMST therapy
Device
Participants use the EMST device as per study protocol, set to 50% of the patient's maximal expiratory pressure, as measured by handheld manometer.
Sham EMST therapy
Device
Participants use a sham EMST device that has the spring removed as per study protocol, with no significant airflow resistance.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in score from week 0 to week 5; change in score from week 0 to week 15; change in score from week 5 to week 15.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly change in score from week 0 to week 5; change in score from week 0 to week 15; change in score from week 5 to week 15. for reporting.

Closest Location

Neuromuscular Clinic, South Health Campus - Calgary, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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.)

Patient Q&A Section

What causes muscular diseases?

"Muscular pathologies can be attributed on a wide range of mechanisms (e.g. genetic, hormonal and environmental factors), the most common being a primary genetic malfunction." - Anonymous Online Contributor

Unverified Answer

How many people get muscular diseases a year in the United States?

"There is one case of amyotrophic lateral sclerosis for every 40,000 to 200,000 US males and 1 case of myasthenia gravis for every 25,200 to 1.5 million US females between the ages of 15 and 74 years. The estimated incidence of muscle disease in US men and women is 2.6 and 2.2 per 100,000 person-years, respectively. The US Department of Health and Human Services (DHHS) estimates the annual direct costs of treating muscular diseases and conditions in 2002–2015 are about $24 billion. The estimated annual cost of these conditions in 2002–2015 is approximately $40 billion." - Anonymous Online Contributor

Unverified Answer

What is muscular diseases?

"It is generally accepted that muscular diseases result in weakness, weakness, or paralysis of the muscles used in the body's functional and physiological movements. These diseases can also cause spasm and twisting of muscles.\n" - Anonymous Online Contributor

Unverified Answer

Can muscular diseases be cured?

"Muscle diseases can be treated with good effect: in all cases the muscles are better at function; in most cases quality of life will also improve. Muscle diseases can often be cured, but not all will fully recover, and the cure level depends much on the seriousness of the underlying disorder." - Anonymous Online Contributor

Unverified Answer

What are common treatments for muscular diseases?

"This presentation defines the scope of treatment for muscular diseases, and is meant to stimulate the creation of novel treatments. Common treatments vary by disease, but often include physical therapy, splints, braces or orthoses; and, depending on the nature of the problem, medications can be used to treat or relieve symptoms, change bowel habits, or improve quality of life." - Anonymous Online Contributor

Unverified Answer

What are the signs of muscular diseases?

"Muscular diseases can be diagnosed using clinical and laboratory techniques. Muscles can be evaluated using biopsy, medical imaging, and electromyography (EMG). Treatment for most muscular diseases require a multiphoton plan, which allows for a combination of procedures for medical imaging and EMG evaluation. For EMG the most common and important procedure is for evaluation of the lower limb muscles." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in expiratory muscle strength therapy (emst150, aspire llc) for therapeutic use?

"A multidisciplinary approach to treating COPD patients is urgently required because of increasing morbidity and mortality associated with this disease. This approach should include the use of emst150 technology. The use of emst150 in the clinical and research setting is safe, feasible, and promising for the therapeutic control of COPD." - Anonymous Online Contributor

Unverified Answer

What does expiratory muscle strength therapy (emst150, aspire llc) usually treat?

"The majority of people (95%) reported improvements in muscle strength and physical function, and approximately 75% reported maintaining these improvements at 1 year of EMST150 treatment. However, more than half reported that their HRQoL worsened, perhaps indicating more urgent care in those who do not see progress on strength or physical function in 1-year follow-up." - Anonymous Online Contributor

Unverified Answer

What is the latest research for muscular diseases?

"In general, our research has revealed that patients with muscular disorders have a higher mortality risks from cancers and cardiovascular diseases. This data is imperative for clinicians since patients with these disorders are especially susceptible to disease complications. Also, our findings demonstrate the importance of physical fitness in muscular disorders and emphasize the potential benefits of physical training programs in maintaining and enhancing muscle performance." - Anonymous Online Contributor

Unverified Answer

Has expiratory muscle strength therapy (emst150, aspire llc) proven to be more effective than a placebo?

"This article presents the results of a randomized trial of EMST and placebo with the purpose of quantitatively assessing differences in exercise capacity and muscle strength between the two groups." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for muscular diseases?

"All patients with a muscle disease or disorder should consider clinical trial participation, particularly for those at early stages of their illness or with comorbid conditions. Participation in clinical trials offers the benefits of the highest quality of medicine to the sickest patients." - Anonymous Online Contributor

Unverified Answer

How does expiratory muscle strength therapy (emst150, aspire llc) work?

"Results from a recent clinical trial show the efficacy of the EMD system in reducing exercise-induced larynx hyperpnea, dyspnea, and stridor in people with dysphagic dysphagia. Additional research is warranted to examine the potential use of the EMD system for muscle strength training." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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