Pediatric Nasal Mask Usability Study

Obstructive Sleep Apnea Clinical Trial

Official title:

Pediatric Nasal Mask Usability Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154322
• Other study ID #: MA-09-09
• Status: Completed
• Phase: N/A
• First received: June 15, 2010
• Last updated: January 18, 2013
• Start date: June 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 7 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	The Children's Hopsital	Aurora	Colorado
United States	Stanford Center for Human Sleep Research	Redwood City	California
United States	Gaylord Sleep Medicine	Wallingford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
ResMed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline AHI	No
Primary	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.	AHI after min 21 days use with Pixi mask	No