Pediatric Nasal Mask Usability Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Steroids for Pediatric Apnea Research in Kids

NCT02180672

Obstructive Sleep Apnea Syndrome

COMPLETED PHASE3

Structured Light Plethysmography in Obstructive Airways Disease

NCT03499938

Pediatric Respiratory Diseases

COMPLETED

Pediatric Mask Fit Study

NCT05942534

Respiratory Tract Infections

COMPLETED

Pediatric Helmet CPAP Pilot Study

NCT04764929

Bronchiolitis, Viral Pneumonia, Viral Pneumonia, Bacterial

TERMINATED NA

Assesment of the Effectiveness of High Frequency Oral Oscillation and Mask of PEP in Children With Pneumonia

NCT02192268

Pneumonia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obstructive Sleep Apnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric mask

Group Type EXPERIMENTAL

Pixi pediatric mask

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No