At a glance
ClinicalIndex Comparison RecordN/ACompleted· 16 enrolled
Drug / intervention
Pixi pediatric maskdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pediatric Nasal Mask Usability Study
In Brief
A clinical study evaluating Pixi pediatric mask for Obstructive Sleep Apnea. Completed, enrolled 16 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionJul 2011
Study CompletionNov 2011
TodayJul 2026
First PostedJun 30, 2010
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2011
Study CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.0 years ago
Interventions
Pixi pediatric maskdevice
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.