Neuromuscular Diseases Clinical Trial
Official title:
Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation: a Randomized Crossover Trial
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.
n/a
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