Pediatric Nasal Mask Usability Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01154322
First received: June 15, 2010
Last updated: January 18, 2013
Last verified: January 2013
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Intervention: Device: Pixi pediatric mask

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pediatric Mask 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.

Participant Flow:   Overall Study
    Pediatric Mask  
STARTED     16  
COMPLETED     14  
NOT COMPLETED     2  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Pediatric Mask 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.

Baseline Measures
    Pediatric Mask  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     16  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     12  
Male     4  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask   [ Time Frame: Baseline AHI ]

2.  Primary:   Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask   [ Time Frame: AHI after min 21 days use with Pixi mask ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
No text entered.  


Results Point of Contact:  
Name/Title: June Mendoza
Organization: ResMed
phone: 1-800-424-0737
e-mail: june.mendoza@resmed.com


No publications provided


Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01154322     History of Changes
Other Study ID Numbers: MA-09-09
Study First Received: June 15, 2010
Results First Received: November 7, 2012
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration