Status:
COMPLETED
3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea
Lead Sponsor:
Glenn Green
Collaborating Sponsors:
American Academy of Otolaryngology-Head and Neck Surgery Foundation
University of Michigan
Conditions:
Sleep Apnea, Obstructive
Craniofacial Abnormalities
Eligibility:
All Genders
1-18 years
Phase:
EARLY_PHASE1
Brief Summary
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 positiv...
Detailed Description
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 cardi...
Eligibility Criteria
Inclusion
- 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
- Subjects no longer needing CPAP therapy
- Subjects able to successfully use a commercially available mask.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02261857
Start Date
September 1 2013
End Date
September 1 2017
Last Update
April 16 2020
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109