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Pediatric Nasal Mask Usability Study

NCT01154322 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2013-01-24

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2011-07-31
Completion
2011-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01154322 on ClinicalTrials.gov