Pediatric Nasal Mask Usability Study

ResMed

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Pixi pediatric mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT01154322

MA-09-09

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Pediatric mask

Experimental group

Treatment:

Device: Pixi pediatric mask