Status:
COMPLETED
Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Association Française contre les Myopathies (AFM), Paris
Hôpital Raymond Poincaré
Conditions:
Neuromuscular Diseases
Alveolar Hypoventilation
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
Nocturnal Non Invasive Ventilation (NIV) is the reference treatment for chronic alveolar hypoventilation in patients with neuro-muscular diseases. NIV can be provided by using different types of inter...
Eligibility Criteria
Inclusion
- Adult patients (\>18 years old)
- Affected by slowly progressive neuro-muscular diseases (Becker muscular dystrophy, facio-scapulo-humeral dystrophy, limb-girdle dystrophy, myotonic dystrophy…) or relatively rapid progression (Duchenne muscular dystrophy).
- Treated with nocturnal non-invasive ventilation (\<15 hours/day)
- In stable state (no cardiorespiratory or ear-nose-throat event for at least 1 month before inclusion)
Exclusion
- Rapidly progressive neuro-muscular diseases (such as ALS)
- Severe nasal obstruction, maxillofacial deformities or previous upper airway surgery preventing the usage of one type of mask (nasal or oronasal), or, at the discretion of investigator, any other contraindication for using the other type of mask
- NIV Daily use \>15h/day
- Unwillingness or inability to provide consent to participation
- Curatorship
- Subject in exclusion period of another study
- Vulnerable person or legally protected adult.
Key Trial Info
Start Date :
May 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03458507
Start Date
May 28 2018
End Date
June 26 2019
Last Update
October 8 2019
Active Locations (1)
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1
Grenoble-Alpes University hospital
Grenoble, France, 38000