Personalized Three-Dimensionally Printed CPAP Masks for Obstructive Sleep Apnea Therapy in Children With Craniofacial Anomalies

Obstructive sleep apnea (OSA) is a common problem in the general pediatric population, generally cited as between 1-5%, with morbidity ranging from daytime behavioral problems and inattention to cardiopulmonary effects including hypertension and ventricular hypertrophy. OSA is dramatically more prevalent among children with certain craniofacial anomalies and syndromes (e.g. Pierre-Robin, Treacher Collins, etc.), generally because of small, short jaws, midface hypoplasia, and/or disproportionally large tongues . While tonsillectomy and adenoidectomy is considered first line therapy for OSA in the general pediatric population, children with OSA due to craniofacial anomalies frequently require more aggressive intervention to improve their breathing at night, which often includes continuous positive airway pressure ventilation (CPAP). Most children who require CPAP therapy are able to find a mask that will adequately seal while providing acceptable comfort, however a small percentage of children encounter significant difficulty finding a functional CPAP interface, most often because of dysmorphic facial features. This can prove a significant barrier to effective CPAP therapy and lead to frustration on the part of patients' caregivers and providers, as well as the associated morbidity of untreated severe OSA. The purpose of this feasibility study is to investigate the use of patient-specific computational design and three-dimensional (3D) printing to produce personalized CPAP masks for children intolerant of standard CPAP masks due to poor fit secondary to craniofacial anomalies who encounter significant difficulty using CPAP because of poorly fitting masks despite exhausting available commercial mask options.

Study Design

This will be a prospective case study examining the feasibility of using patient-specific CAD and 3D printing technology to produce personalized CPAP masks for children intolerant of commercially available masks due to poor fit. Patients will be recruited from the pediatric otolaryngology, pediatric oral maxillofacial surgery, and pediatric sleep clinics at the University of Michigan Medical Center, with a target cohort of five.

Only patients of study team members will be included in the study, and no recruitment will take place outside the clinics of participating study team members. We anticipate the study period to last 3 years, though it may terminate sooner if recruitment targets are reached expeditiously.

After recruitment and consent of a potential study subject, each subject will undergo an initial mask-design evaluation with members of the research team. At this initial visit, the following will be performed: