Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Usability and Efficacy of a New Pediatric CPAP Mask

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01312948
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : March 19, 2012
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
ResMed

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Obstructive Sleep Apnea
Respiratory Insufficiency
Intervention Device: Prototype mask (known as Pixi)
Enrollment 6
Recruitment Details Participants were recruited from Mater Children's Hospital patient database. Patients were recruited from January - April 2011. Participants attended Mater Children's Hospital Sleep Unit to take part in the study
Pre-assignment Details  
Arm/Group Title Prototype Mask
Hide Arm/Group Description New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
Period Title: Overall Study
Started 6
Completed 6
Not Completed 0
Arm/Group Title Prototype Mask
Hide Arm/Group Description New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
6
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
4.6  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
2
  33.3%
Male
4
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 6 participants
6
1.Primary Outcome
Title Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask
Hide Description

Before trialling the Pixi mask, parents rated the usability of their child's usual mask using a 0-10 Likert Scale where 0 = poor and 10 = excellent. After trialling the Pixi mask, parents then completed the same questionnarie for the Pixi mask.

Usability was defined as a single overall score of mask performance. Parents considered mask seal, comfort, stability and red marks when scoring each mask for usability.

Time Frame 8 nights use
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was as per protocol
Arm/Group Title Pixi Paediatric Mask Usability Usual Mask
Hide Arm/Group Description:
Usability (overall performance) score of the Pixi paediatric mask
Usability (overall performance) score of the child's usual CPAP mask
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.17  (2.93) 5.83  (1.94)
2.Secondary Outcome
Title Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask
Hide Description Apnea-Hypopnea index (AHI) is a measure of the severity of sleep disordered breathing (SDB). It describes how many events of compromised breathing occur each hour of sleep. 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 patients usual mask
Time Frame >4 hours monitored sleep study
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was as per protocol
Arm/Group Title Pixi Paediatric Mask Usual Mask
Hide Arm/Group Description:
Apnea hypopnoea index from a monitored sleep study of the new Pixi mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
Apnea hypopnoea index from a monitored sleep study of the child's usual CPAP mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
Overall Number of Participants Analyzed 6 6
Mean (Standard Deviation)
Unit of Measure: apnea hypopnoea index
0.85  (0.76) 3.25  (1.57)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prototype Mask
Hide Arm/Group Description New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
All-Cause Mortality
Prototype Mask
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Prototype Mask
Affected / at Risk (%)
Total   0/6 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Prototype Mask
Affected / at Risk (%)
Total   0/6 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alison Wimms
Organization: ResMed Ltd
Phone: +6188842583
EMail: alison.wimms@resmed.com.au
Layout table for additonal information
Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01312948    
Other Study ID Numbers: MA13122010
First Submitted: February 6, 2011
First Posted: March 11, 2011
Results First Submitted: October 31, 2011
Results First Posted: March 19, 2012
Last Update Posted: June 26, 2017