Pediatric Nasal Mask Usability Study

NCT01154322 | Completed Results

• 1 other identifier: MA-09-09
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Pediatric mask

EXPERIMENTAL

Device: Pixi pediatric mask

Interventions

Pixi pediatric mask DEVICE

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.

Pediatric mask

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years of age
• Diagnosis of OSA
• Current PAP therapy user
• Current nasal mask user

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (3)

Stanford Center for Human Sleep Research

Redwood City, California, 94063, United States

Location

The Children's Hopsital

Aurora, Colorado, 80045, United States

Location

Gaylord Sleep Medicine

Wallingford, Connecticut, 06492, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: June Mendoza
• Organization: ResMed

june.mendoza@resmed.com

1-800-424-0737

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 24, 2013
• Results First Posted: January 16, 2013

Record last verified: 2013-01

Locations

US (3)