title: Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial.
abstract: BACKGROUND
  Patient interface is important for the success of continuous positive airway pressure (CPAP), but few trials have examined the influence of mask choice on CPAP adherence.
  
  
  OBJECTIVE
  To compare the impact of different nasal masks on CPAP in patients with newly-diagnosed obstructive sleep apnea (OSA).
  
  
  METHODS
  OSA patients were randomized in a 2:3 ratio to receive CPAP via different first-line nasal masks: ResMed Mirage FX® (MFX) or control mask (Fisher & Paykel Zest®, HC407®or Philips EasyLife®). Mask acceptance, CPAP compliance and Home Care Provider (HCP) interventions were compared between groups after 3 months of CPAP therapy using modified intent-to-treat (mITT; after exclusion of patients with mouth leaks during CPAP initiation) and on-treatment (OT; CPAP adherent) analyses.
  
  
  RESULTS
  Of 285 randomized patients, 90 requiring a full-face mask were excluded, leaving 195 and 151 in the mITT and OT analyses, respectively. Mask acceptance rate was higher in the MFX versus control group (mITT: 79% vs 68%, P = 0.067; OT: 90% vs 76%, P = 0.022). CPAP compliance was higher (5.9 ± 1.8 vs 5.1 ± 1.6 h/night, P = 0.011) and nasal mask issue-related HCP visits lower (3% vs 17%, P = 0.006) in the MFX group. Nasal mask failures due to mask discomfort (5% vs 1%) or unintentional leakage (5% vs 0%) were higher in control vs MFX group. Mask acceptance was significantly associated with fewer mask leaks (P = 0.002) and higher pressure therapy (P = 0.042).
  
  
  CONCLUSIONS
  This study highlights differences between nasal masks for CPAP delivery and shows that initial mask selection can influence adherence and healthcare utilization during CPAP.
authors.affiliation: ResMed Science Center, Saint Priest cedex, France.
authors.forename: Pierre-Charles
authors.initials: PC
authors.lastname: Neuzeret
authors.affiliation: ResMed Science Center, Saint Priest cedex, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Morin
mesh_terms: D000328:Adult; D000368:Aged; D045422:Continuous Positive Airway Pressure / Q000295:instrumentation*; D003695:Delivery of Health Care / Q000706:statistics & numerical data; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008397:Masks / Q000009:adverse effects* / Q000592:standards; D008875:Middle Aged; D009666:Nose; D017063:Outcome Assessment, Health Care; D010349:Patient Compliance / Q000706:statistics & numerical data; D017060:Patient Satisfaction; D011446:Prospective Studies; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis* / Q000628:therapy
keywords: acceptance; compliance; continuous positive airway pressure; health care utilization; nasal mask; randomized controlled trial