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Pediatric Nasal Mask Usability Study

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ClinicalTrials.gov Identifier: NCT01154322
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : January 16, 2013
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):
ResMed

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Obstructive Sleep Apnea
Intervention Device: Pixi pediatric mask
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pediatric Mask
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 16
Completed 14
Not Completed 2
Arm/Group Title Pediatric Mask
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
16
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
12
  75.0%
Male
4
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Apnea-hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask
Hide Description Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). 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 child's usual mask.
Time Frame Baseline AHI
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed all visits and procedures
Arm/Group Title Currently-used Mask
Hide Arm/Group Description:
Baseline AHI prior to Pixi mask use
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: AHI (events/hour)
2.7  (5.6)
2.Primary Outcome
Title Apnea-Hypopnea Index (AHI) Using the New Pediatric Mask (Pixi) Compared to the Child's Currently-used Mask
Hide Description Apnea-Hypopnea index (AHI) is an average of the number of apneas and hypopneas that occur over an hour of recorded sleep. AHI quantifies the severity of sleep disordered breathing (SDB). 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 child's usual mask.
Time Frame AHI after min 21 days use with Pixi mask
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pixi Mask
Hide Arm/Group Description:
AHI with Pixi mask
Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: AHI (events/hour)
1.2  (1.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Overall Study
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Overall Study
Affected / at Risk (%) # Events
Total   1/16 (6.25%)    
Nervous system disorders   
Seizure [1]  1/16 (6.25%)  1
[1]
Seizure unrelated to use of PAP/Pixi mask
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Overall Study
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
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.
Results Point of Contact
Name/Title: June Mendoza
Organization: ResMed
Phone: 1-800-424-0737
Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01154322     History of Changes
Other Study ID Numbers: MA-09-09
First Submitted: June 15, 2010
First Posted: June 30, 2010
Results First Submitted: November 7, 2012
Results First Posted: January 16, 2013
Last Update Posted: January 24, 2013