Pediatric Nasal Mask Usability Study

ResMed16 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 7 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used 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.

Time frame: Baseline AHI

Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used 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.

Time frame: AHI after min 21 days use with Pixi mask

Data from ClinicalTrials.gov

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