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Pediatric Nasal Mask Usability Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT01154322

Pediatric Nasal Mask Usability Study

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

Lead sponsor: ResMed•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

ResMed

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.

Age

2 - 7 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 24, 2013Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment16

Start dateJun 2010

Last updatedJan 24, 2013

Condition

Obstructive Sleep Apnea

Locations shown

Stanford Center for Human Sleep Research

Redwood City, California

The Children's Hopsital

Aurora, Colorado

Gaylord Sleep Medicine

Wallingford, Connecticut

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2013Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions