Pediatric Nasal Mask Usability Study

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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

Key facts

Study ID

NCT01154322

Run by

ResMed

People needed

16

Starts

2010-06-01

Expected to finish

2011-11-01

Last updated by the study team

2013-01-24

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 2-7 years of age
• Diagnosis of OSA
• Current PAP therapy user
• Current nasal mask user

You may not qualify if…

• Recent sinus surgery
• Allergies to mask material
• Current seasonal allergies that could interfere with therapy
• History of clinically significant epistaxis in past 6 months
• Upper airway surgery less than 60 days before study entry

Where it is running

• Stanford Center for Human Sleep Research — Redwood City, California, United States
• The Children's Hopsital — Aurora, Colorado, United States
• Gaylord Sleep Medicine — Wallingford, Connecticut, United States

Full record on ClinicalTrials.gov

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