3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea
Sleep Apnea, Obstructive, Craniofacial Abnormalities, Pediatric Disorder
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring Obstructive Sleep Apnea, Craniofacial Abnormalities, Pediatrics, Computer-Aided Design, Continuous Positive Airway Pressure, Three-Dimensional Printing, Additive Manufacturing
Eligibility Criteria
Inclusion Criteria:
- On-going need for CPAP therapy based on polysomnography
- Inability to tolerate CPAP attributed to poor fit by a sleep clinician
- The opinion of a sleep clinician that reasonable commercially available mask options have been exhausted
- Caregivers must also be proficient in English to complete standard questionnaires.
Exclusion Criteria:
- Subjects no longer needing CPAP therapy
- Subjects able to successfully use a commercially available mask.
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Intervention Arm
Historical Control Arm
Intervention: Subjects will undergo assessment and a personalized CPAP mask device will be manufactured using patient-specific computer-aided design and 3D printing. The subject will use the personalized CPAP mask for 1 month of consistent use and post-intervention data will be collected for compare to historical control (see other arm)
Pre-interventional baseline data on subject OSA, CPAP compliance, and quality of life (QoL) measures will be collected to serve as historical controls.