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

NCT02261857 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2020-04-16

No results posted yet for this study

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 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.

Conditions

  • Sleep Apnea, Obstructive
  • Craniofacial Abnormalities
  • Pediatric Disorder

Interventions

DEVICE

Personalized continuous positive airway pressure (CPAP) mask

Personalized CPAP mask manufactured for study subjects using a combination of patient-specific computer-aided design and three-dimensional printing

Sponsors & Collaborators

  • American Academy of Otolaryngology-Head and Neck Surgery Foundation

    collaborator OTHER

  • University of Michigan

    collaborator OTHER

  • Glenn Green

    lead OTHER

Principal Investigators

  • Glenn E Green, MD · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2017-09-30
Completion
2017-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261857 on ClinicalTrials.gov