Conventional vs custom made nasal Continuous Positive Airway Pressure (CPAP) mask for treatment of Obstructive Sleep Apnoea: Pilot study A

Maximum total duration of the study is 7 weeks, from enrollment to conclusion of the third visit. Duration of the first visit is 15 minutes. An eligible participant, who owns and is currently using their CPAP machine with conventional nasal CPAP mask (any commercial brand), will have their face scanned by a purpose-built portable 3D scanner. The scan takes 60 seconds, and is performed once. The scanned information is then instantly transferred to a secured server that can only be accessed by the study coordinator and a qualified engineer of the 3D scanner's company. The information is used for 3D printing of a custom made nasal CPAP mask. The mask is printed by the engineer using the company's purpose-built high-tech 3D printing. The printing process takes approximately 2 weeks. The study coordinator has been trained to operate the scanner and to fit the mask by the company’s engineer prior to the study's recruitment. Duration of the second visit is 30 minutes. The visit takes place when the custom made nasal CPAP mask is ready for fitting. During this visit, the participant will have CPAP usage data during the 4 weeks prior to this second visit downloaded from the machine SIM card by the study coordinator using a commercially available software for CPAP data capture and analysis. Patient has been using their own CPAP machine prior to enrollment. The CPAP machine records its usage as part of its functionalities/clinical routine. Therefore, the 4 weeks of CPAP usage data is approximately 2 weeks prior to enrollment plus 2 weeks from the first visit to the second visit (while the custom made mask is being made). No training is required as the study coordinator is already experienced in using the software. The participant will be fitted with their custom made nasal CPAP mask by the study coordinator. He/She will be educated on the use of the CPAP mask, including how to properly wear the mask, and proper cleaning technique by verbal instruction only from the study coordinator. There is no minimum or maximum time limit for nightly use of the custom made nasal CPAP mask, and the usage will not be monitored. Duration of the third visit is 15 minutes. This visit takes place 4 weeks after the second visit. During this visit, the participant will have CPAP usage data during the 4 weeks since the second visit downloaded from the machine SIM card by the study coordinator. A custom made nasal CPAP mask will be provided to all participants in the study at no cost. Participants will be permitted to retain their custom made nasal CPAP masks free of charge at the conclusion of the study if deemed clinically useful by their treating sleep physicians.