Pediatric Nasal Mask Usability Study - Full Text View

Purpose

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

Condition	Intervention
Obstructive Sleep Apnea	Device: Pixi pediatric mask

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pediatric Nasal Mask Usability Study

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by ResMed:

Primary Outcome Measures:

Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask [ Time Frame: Baseline AHI ] [ Designated as safety issue: No ]
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 [ Time Frame: AHI after min 21 days use with Pixi mask ] [ Designated as safety issue: No ]
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.

Enrollment:	16
Study Start Date:	June 2010
Study Completion Date:	November 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pediatric mask	Device: Pixi pediatric mask 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.

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.

Eligibility

Ages Eligible for Study:	2 Years to 7 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154322

Locations

United States, California
Stanford Center for Human Sleep Research
Redwood City, California, United States, 94063
United States, Colorado
The Children's Hopsital
Aurora, Colorado, United States, 80045
United States, Connecticut
Gaylord Sleep Medicine
Wallingford, Connecticut, United States, 06492

Sponsors and Collaborators

ResMed

More Information

No publications provided

Responsible Party:	ResMed
ClinicalTrials.gov Identifier:	NCT01154322 History of Changes
Other Study ID Numbers:	MA-09-09
Study First Received:	June 15, 2010
Results First Received:	November 7, 2012
Last Updated:	January 18, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases

Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013