Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation (InterfaceNMD)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Alveolar Hypoventilation; Neuromuscular Diseases

Treatments: Device: Switch of nocturnal NIV interface

Study type: Interventional

Funder types: Other

Identifiers

NCT03458507

38RC17.346

Details and patient eligibility

About

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 interfaces: Nasal masks are the most frequent type of interface used at home but oronasal masks are used by at least 25% of neuro-muscular patients mainly because of persistent unintentional mouth leaks. However, oronasal mask may cause persistent upper airway obstructive respiratory events because of the mechanical constraint on the chin induced by the traction of the straps that may push the mandible posteriorly during sleep.

No randomized study has specifically addressed the question of the impact of type of interface in patients with neuromuscular diseases treated by nocturnal NIV.

The investigators hypothesize that:

1. the application of oronasal mask may jeopardize the pharyngeal patency in patients already proned to upper airway obstruction;
2. the use of a nasal mask may improve upper airway stability and NIV efficacy while reducing side effects.

Authors objective will be to compare the impact of nasal mask versus oronasal mask on NIV efficacy and side-effects. Eligible patients are those with nocturnal NIV and neuromuscular disease.

After a scheduled hospital visit, patients willing to participate will undergo in random order 2 unattended nocturnal polygraphies under NIV at home: one polygraphy with nasal mask; one with an oronasal mask. Each polygraphy ans side effects assessment will be performed after one week of familiarization with each mask.

Enrollment: 30 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Usual interface

Active Comparator group

Description:

Patients which begin with their usual interface for one week, home polygraphy and side effect assessment at the end of the first week. Switch for alternative interface, seven days familiarisation, second polygraphy and side effect assessment at the end of the second week.

Treatment:

Device: Switch of nocturnal NIV interface

Alternative interface

Active Comparator group

Description:

Patients which begin with the alternative interface for one week, home polygraphy and side effect assessment at the end of the first week. Switch for usual interface, seven days with usual device, second polygraphy and side effect assessment at the end of the second week.

Treatment:

Device: Switch of nocturnal NIV interface