Evaluating Dyspnea in Autoimmune Myasthenia Gravis "why Am I Short of Breath?"

Not yet recruiting

• Conditions: Myasthenia Gravis; Dyspnea

• Registration Number: NCT06866652
• Lead Sponsor: Institut de Myologie, France

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.

Detailed Description

MYaResp is a prospective observational, cross-sectional study to evaluate dyspnea in adults with autoimmune myasthenia gravis.

Study aims include to:

* Describe the characteristics of dyspnea in IwMG

* Understand contributing factors and factors associated with dyspnea in IwMG including the relationship between patient-reported dyspnea, disease severity and functional limitations.

* Determine the most effective tests to identify the causes and contributing factors of dyspnea

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Study Start: 2025-05
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dyspnea questionnaires	baseline	Dyspnea-12

Secondary Outcome Measures

Name	Time	Method
cardiopulmonary exercise test	baseline	cycle ergometer
Polysomnography	baseline	evaluation of sleep disordered breathing
Functional measures	baseline	6 minute walk test
Quality of life questionnaires	baseline	Revised version of the myasthenia gravis quality of life questionnaire (Burns, French validation Birnbaum)
Anxiety and depression	baseline	Hospital Anxiety and Depression Scale

Trial Locations

Locations (1)

Institute of Myology; 🇫🇷 Paris, France