Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation
Condition: Neuromuscular Diseases; Alveolar Hypoventilation
MeSH terms: Hypoventilation; Neuromuscular Diseases
Study type: Interventional

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 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.
    


Intervention name(s): Switch of nocturnal NIV interface
Intervention type(s): Device
Intervention description(s): test the alternative interfaces (either a nasal mask for the patient used to oronasal mask or inversely an oronasal mask if the usual mask is nasal) during a one-hour diurnal NIV session. SpO2 (polygraphy), PtcCO2 will be monitored continuously during this diurnal session. Patients will use their usual NIV device prescribed at home. NIV settings will be adapted if needed.
Interface switch
unattended nocturnal polygraphy under NIV (cf details below) will be performed at home with SomnoHolter® (Nomics, Liege, Belgium), synchronized with transcutaneous partial pressure in CO2 (PtcCO2) monitoring by SenTec V-Sign™ System.
The PtcCO2 device will be calibrated before and at the end of each night to allow drift correction.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The patients will be randomized for two periods of one week to use NIV either with nasal or oronasal mask. The randomization will be stratified according to the type of interface previously used at home by the patient (nasal and oronasal). Such stratification will allow a balance between the number of patients that will begin with their usual interface versus with an alternative interface. In these patients, NIV withdrawal is not acceptable in terms of patient's security and ethics. Therefore, it is not possible to include a wash out period between both arms. The potential carry-over effect will be taken into account in the statistical analysis.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Neuromuscular diseases; Non-invasive ventilation; Nasal mask; Oronasal mask; Alveolar hypoventilation; leaks; Sleep disorder breathing; Side effects