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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01312948
First received: February 6, 2011
Last updated: April 9, 2012
Last verified: August 2011
History of Changes
Results First Received: October 31, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Obstructive Sleep Apnea
Respiratory Insufficiency
Intervention: Device: Prototype mask (known as Pixi)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Prototype Mask New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy

Participant Flow:   Overall Study
    Prototype Mask  
STARTED     6  
COMPLETED     6  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Prototype Mask New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy

Baseline Measures
    Prototype Mask  
Number of Participants  
[units: participants]
 		  6  
Age  
[units: participants]
 		 
<=18 years     6  
Between 18 and 65 years     0  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  4.6  ± 1.8  
Gender  
[units: participants]
 		 
Female     2  
Male     4  
Region of Enrollment  
[units: participants]
 		 
Australia     6  



  Outcome Measures
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1.  Primary:   Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask   [ Time Frame: 8 nights use ]
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2.  Secondary:   Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask   [ Time Frame: >4 hours monitored sleep study ]
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  Serious Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
Prototype Mask New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy

Serious Adverse Events
    Prototype Mask  
Total, serious adverse events    
# participants affected / at risk     0/6 (0.00%)  




  Other Adverse Events
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  More Information
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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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Alison Wimms
Organization: ResMed Ltd
phone: +6188842583
e-mail: alison.wimms@resmed.com.au


No publications provided


Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01312948     History of Changes
Other Study ID Numbers: MA13122010
Study First Received: February 6, 2011
Results First Received: October 31, 2011
Last Updated: April 9, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration