3D Printing of Positive Airway Pressure (PAP) Therapy Masks: a Single Site Pilot and Feasibility Study

Stage 1: 10 health participants. subjects will be asked to attend for a mask fitting using off the shelf standard mask stock. They will then be trialed on PAP therapy (breathing machine) for 10 minutes. Mask leak, skin reactions and comfort scores will be assessed. Subjects will then attend for 3D printing of a mask. Following the production of the 3D mask, repeat measurements with the 3d mask on PAP therapy will be taken. If all healthy subjects complete the trial without any serious adverse events, then the second phase of the study with patients will commence. Stage 2: Patients with an established diagnosis of sleep disordered breathing with known mask concerns will be recruited from the Royal Free London NHS Foundation Trust (RFL) Sleep and Ventilation Service. Subjects will be asked to attend for a mask fitting using their existing mask standard stock and will be trialed on PAP therapy (breathing machine) for 10 minutes. Mask leak, skin reactions and comfort scores will be assessed. Any side effects will be documented via photographs. The number and cost of previous masks used since starting PAP therapy (breathing machine) will be also be recorded. Patients will then attend for 3D printing of a mask and repeat measurements with the 3D mask on 10 minutes of their usual PAP therapy will be taken. If there are no serious adverse events/reactions during the PAP trial with the 3D printed mask patients will go on to have a one-night trial on PAP therapy as per their normal PAP (breathing machine) regime. If there are no adverse events or reactions during the one-night trial then patients will proceed to a further four nights of trial with the 3D printed mask. A comparison of scores will be made with standard and 3D printed masks.