Suspended

Interventional Study of Expiratory Muscle Strength Training as a Treatment in Neuromuscular Disorders

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What is being tested

Expiratory muscle strength therapy (EMST150, Aspire LLC)

Device
Who is being recruted

Deglutition Disorders+12

+ Digestive System Diseases

+ Esophageal Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: May 2022
See protocol details

Summary

Principal SponsorUniversity of Calgary
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2022

Actual date on which the first participant was enrolled.

Outline: Twenty participants with OPMD, with dysphagia, will be recruited from Neuromuscular clinics within Calgary. The investigators will enrol patients in a parallel group, sham-controlled, randomized clinical trial, with 10 participants in each group (active EMST and sham EMST). Participants will have baseline measurements of: (i) global swallowing function via modified barium swallow study, (ii) maximum expiratory pressure, (iii) voluntary cough spirometry, (iv) forced vital capacity, (v) functional oral intake, (vi) patient report of self-perceived swallowing impairment (EAT-10 Questionnaire), and (vii) biomarker analyses. Participants will undergo 5-weeks of EMST (active or sham). All baseline measurements will be repeated after 5-weeks of EMST and 10-weeks post-EMST to measure durability of effect. Outcomes: The end-goal of the current research is to obtain preliminary data for the benefit of EMST in a new study population, and direct future studies that may provide evidence for a new standard of care in treating neuromuscular diagnoses.

Official TitleInterventional Study of Expiratory Muscle Strength Training as a Treatment in Neuromuscular Disorders
NCT04009408
Principal SponsorUniversity of Calgary
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Deglutition DisordersDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesMuscular DiseasesMuscular DystrophiesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeuromuscular DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesMuscular Disorders, AtrophicGenetic Diseases, InbornMuscular Dystrophy, Oculopharyngeal

Criteria

7 inclusion criteria required to participate
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

Show More Criteria

10 exclusion criteria prevent from participating
Severe coronary artery disease

Acute myocardial infarction

Moderate to severe hypovolemia

Acute neurological events

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Participants use the EMST device as per study protocol, set to 50% of the patient's maximal expiratory pressure, as measured by handheld manometer.

Group II

Sham
Participants use a sham EMST device that has the spring removed as per study protocol, with no significant airflow resistance.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Neuromuscular Clinic, South Health Campus

Calgary, CanadaOpen Neuromuscular Clinic, South Health Campus in Google Maps
SuspendedOne Study Center
Interventional Study of Expiratory Muscle Strength Training as a Treatment in Neuromuscular Disorders | PatLynk