Pediatric Nasal Mask Usability Study

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Pixi pediatric mask

• Registration Number: NCT01154322
• Lead Sponsor: ResMed

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 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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-15
• Study First Submitted QC: 2010-06-28
• Study First Posted: 2010-06-30
• Primary Completion: 2011-07
• Study Completion: 2011-11
• Results First Submitted: 2012-11-07
• Results First Submitted QC: 2012-12-10
• Status Verified: 2013-01
• Results First Posted: 2013-01-16
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric mask	Pixi pediatric mask	-

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask	Baseline AHI	Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe \>30). In clinical practice an AHI \<5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask, and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.
Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask	AHI after min 21 days use with Pixi mask	Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). The higher the AHI, the more severe the SDB (mild 5-15, moderate 15-30, severe \>30). In clinical practice an AHI \<5 demonstrates efficacy of treatment. AHI was recorded during a monitored sleep study on the new Pixi mask and compared with the AHI from a monitored sleep study on the child's usual mask. The outcome hypothesis was that the Pixi mask AHI would be equivalent or reduced compared to the child's usual mask.

Trial Locations

Locations (3)

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