Evaluating Dyspnea in Autoimmune Myasthenia Gravis "Why am I Short of Breath?"

NCT06866652 | Not Yet Recruiting

• 1 other identifier: MyaRESP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with MG (IwMG) experience shortness of breath that may be activity-related, occur at rest and even happen during sleep. Dyspnea is a complex, multidimensional and multifactorial symptom involving sensory perception, cognition and emotion. Identifying the cause(s) of dyspnea in MG may assist in finding therapeutic strategies, reducing discomfort, improving QoL and potentially limiting respiratory deterioration and incidence of MG crisis.

Conditions

Myasthenia Gravis; Dyspnea

Keywords

dyspnea; breathlessness; respiratory

Outcome Measures

Primary Outcomes (1)

• Dyspnea questionnaires

  Dyspnea-12

  baseline

Secondary Outcomes (5)

• cardiopulmonary exercise test

  baseline

• Polysomnography

  baseline

• Functional measures

  baseline

• Quality of life questionnaires

  baseline

• Anxiety and depression

  baseline

Other Outcomes (2)

• impact of myasthenia in daily living

  baseline

• Respiratory pressures

  baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age ≥18 Confirmed diagnosis of autoimmune MG Shortness of breath in daily life: score 1 or 2 on the respiration item on the MG- activities of daily living score

You may qualify if:

• Age ≥18
• Confirmed diagnosis of autoimmune MG
• Shortness of breath in daily life: score 1 or 2 on the respiration item on the MG- activities of daily living score
• Signed consent form
• Affiliated to or beneficiary of a social security scheme

You may not qualify if:

• Known Pregnancy
• Known respiratory disorder (other than MG)
• Recent (within past 4 weeks) respiratory infection
• Current MG crisis or exacerbation (necessitating increase in MG medication \&/or hospital admission)
• No dyspnea - score 0 or 3 on the respiration item on the MG- activities of daily living score
• Severe cognitive impairment/guardianship

Sponsors & Collaborators

• Institut de Myologie, France: lead
• APHP: collaborator

Study Sites (1)

Institute of Myology

Paris, France

Location

MeSH Terms

Conditions

Myasthenia Gravis; Dyspnea

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 10, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)