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Pediatric Nasal Mask Usability Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01154322
First received: June 15, 2010
Last updated: January 18, 2013
Last verified: January 2013

June 15, 2010
January 18, 2013
June 2010
July 2011   (final data collection date for primary outcome measure)
  • 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.
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Complete list of historical versions of study NCT01154322 on ClinicalTrials.gov Archive Site
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Pediatric Nasal Mask Usability Study
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obstructive Sleep Apnea
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.
Experimental: Pediatric mask
Intervention: Device: Pixi pediatric mask
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2011
July 2011   (final data collection date for primary outcome measure)

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
Both
2 Years to 7 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01154322
MA-09-09
No
ResMed
ResMed
Not Provided
Not Provided
ResMed
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP