3DPiPPIN: 3D printing of positive airway pressure (PAP) therapy interfaces: a single site feasibility study.

Sleep-disordered breathing (SDB) affects 14% of the population. Positive airway pressure (PAP) therapy is standard, but commercially available interfaces may be ineffective due to poor fit. Three-dimensional (3D) printing can customise PAP therapy interfaces. Is it feasible to manufacture and use 3D-printed customised oronasal PAP interfaces in clinical practice? Do customised interfaces improve patient comfort and reduce side effects compared to off-the-shelf interfaces? A single-site feasibility study involving 10 healthy and 10 patient participants was undertaken. A 3D facial scan was used to 3D print a mould, injected with medical-grade silicone to create a oronasal customised interface. Participants underwent a 10-minute trial with both off-the-shelf and customised interfaces. Comfort (Visual Analogue Scale), skin reactions, and interface leak (L/min) were measured. Patient participants used the customised interface for five nights at home, with data collected on Apnoea Hypopnoea Index (AHI), interface leak, and PAP therapy concordance. The study recruited 20 participants. Customised oronasal interfaces showed a failure rate in manufacturing (23.75% 3D printing, 50%: silicone injection). Adverse reactions were 10% in the patient study. Comfort scores were similar between interfaces. Interface leak was lower with customised interfaces after five nights. AHI was reduced with customised interfaces, but with a trend towards decreased PAP therapy concordance. The study demonstrated 3D-printed customised oronasal PAP interfaces can be manufactured, with potential benefits of reduced interface leak and AHI. Improvements in manufacturing processes are needed to reduce failure rates. Further research via a randomised controlled trial with a longer duration is warranted.