Impact of different nasal masks on CPAP therapy for obstructive sleep apnea: a randomized comparative trial.

INTRODUCTION: 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.

OBJECTIVES: 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.