NCT01154322

Pediatric Nasal Mask Usability Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 2 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.

Detailed description

Obstructive sleep apnea (OSA) is a condition in which there is partial or complete collapse of the upper airway during sleep. Features of OSA include snoring to upper airway resistance, which could be mild to severe. While OSA has been studied extensively in an adult population, research indicates that OSA is prevalent in a pediatric population as well, though the options for treatment are not as varied as that for the adult population. The study seeks to determine if a mask made for a pediatric population effectively treats their OSA.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Pixi pediatric mask	The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-07-01
• Completion: 2011-11-01
• First posted: 2010-06-30
• Last updated: 2013-01-24
• Results posted: 2013-01-16

Locations

3 sites across 1 country: United States