Status:
COMPLETED
Pediatric Nasal Mask Usability Study
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
2-7 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 2-7 years of age
- Diagnosis of OSA
- Current PAP therapy user
- Current nasal mask user
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01154322
Start Date
June 1 2010
End Date
November 1 2011
Last Update
January 24 2013
Active Locations (3)
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1
Stanford Center for Human Sleep Research
Redwood City, California, United States, 94063
2
The Children's Hopsital
Aurora, Colorado, United States, 80045
3
Gaylord Sleep Medicine
Wallingford, Connecticut, United States, 06492