3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea

Completed · Early Phase 1

Conditions studied: Sleep Apnea, Obstructive, Craniofacial Abnormalities, Pediatric Disorder

In brief

The purpose of this study is to determine whether patient-specific computer-aided design (CAD) and three-dimensional (3D) printing can be utilized to produce personalized, effective continuous positive airway pressure (CPAP) masks for children with severe obstructive sleep apnea (OSA) and craniofacial anomalies who encounter significant difficulty using CPAP because of poorly fitting masks despite exhausting available commercial mask options.

Key facts

Study ID

NCT02261857

Run by

Glenn Green

People needed

8

Starts

2013-09-01

Expected to finish

2017-09-01

Last updated by the study team

2020-04-16

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects no longer needing CPAP therapy
• Subjects able to successfully use a commercially available mask.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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