Clinical impact of customised positive airway pressure (PAP) therapy interfaces (3DPiPPIn): a single site randomised controlled trial.

INTRODUCTION

Positive airway pressure (PAP) therapy is the recognised treatment for sleep disordered breathing (SDB), delivered via a tight-fitting face mask (interface). Conventional interfaces do not consider facial geometries, often resulting in poor fit and ineffective therapy. Three-dimensional (3D) printing of customised interfaces may improve comfort and outcomes.

OBJECTIVES

To evaluate the clinical impact of customised versus conventional oronasal interfaces in adults with obstrcutive sleep apnoea (OSA). The primary outcome was residual Apnoea Hypopnea Index (AHI) at 6 months; secondary outcomes included interface leak, therapy concordance and patient reported symptoms.

METHODS

A randomised controlled trial with 160 adults naïve to PAP therapy and diagnosed with SDB (AHI ≥15 events/hour). Randomisation was minimised by age and ethnicity. Structured light facial scans (POP2, Revopoint, China) were used to produce 3D printed moulds (Fuse 30+, Formlabs, Massachusetts, USA) for silicone injected oronasal customised interface cushions.AHI was compared using quantile regression to account for the skewed distribution of the AHI data. Secondary outcomes were compared using logistic, quantile and linear regressions.

RESULTS

160 participants were recruited (intervention: 82, control: 78). Customised interfaces were associated with a 1.5 (events/hour) increase in AHI (p=0.059), higher interface leak (difference in medians 30.0 L/min, 95% CI 7.36 to 40.14, p<0.0001) and lower compliance (difference in compliance 0.78, 95% CI 0.05 to 1.54, p=0.04) at 6 months.

CONCLUSIONS

This trial did not demonstrate customised oronasal interfaces were superior to conventional interfaces. Future research should focus on addressing design and manufacturing limitations before any potential advantages can be evaluated.

TRIAL REGISTRATION NUMBER: ISRCTN74082423.