Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Pediatric Sleep Apnea
  • Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 25 years
Gender
Both males and females

Description

The aim of this study is to improve adherence and effectiveness of noninvasive ventilation by decreasing the side effects commonly seen with noninvasive ventilation. Studies have shown that even though noninvasive ventilation (NIV) with positive airway pressure (PAP) is successful at treating obstru...

The aim of this study is to improve adherence and effectiveness of noninvasive ventilation by decreasing the side effects commonly seen with noninvasive ventilation. Studies have shown that even though noninvasive ventilation (NIV) with positive airway pressure (PAP) is successful at treating obstructive sleep apnea and hypoventilation, individuals have poor compliance with therapy. The reasons for poor compliance are numerous, but one significant and continually reported reason is poor mask fit. A poor mask fit is not only uncomfortable, but frequently causes side effects such as dry eyes, congestion, skin irritation and breakdown, and ineffective ventilation from inadequate pressures due to air leaking around the mask. Pediatric patients tend to be especially difficult to fit with conventional masks because of their smaller facial features and the lack of masks developed for pediatric use. In this study, patients will be fitted with a custom made NIV mask following facial imaging with a 3D camera (Artec 3D Scanner). The facial image will be used to construct an NIV mask model using computer design software that will then be created by using a 3D printer.

Tracking Information

NCT #
NCT02896751
Collaborators
Not Provided
Investigators
Principal Investigator: Narong Simakajornboon, MD Cincinnati Children's Hopital Medical Center