N/A
N=16
Pediatric Nasal Mask Usability Study
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01154322 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Jan 2013
Primary outcome: Primary: Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask — 2.7 AHI (events/hour)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pixi pediatric mask (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask |
1.2 | — |
| PRIMARY Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask |
1.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 2-7 years of age
- Diagnosis of OSA
- Current PAP therapy user
- Current nasal mask user
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01154322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.