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

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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

Tracking Information
First Submitted Date  ICMJE February 6, 2011
First Posted Date  ICMJE March 11, 2011
Results First Submitted Date  ICMJE October 31, 2011
Results First Posted Date  ICMJE March 19, 2012
Last Update Posted Date June 26, 2017
Study Start Date  ICMJE January 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2012)
Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask [ Time Frame: 8 nights use ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
Improved usability of the new Pixi mask compared with the patient's current mask [ Time Frame: 8 nights use ]
The primary outcome is to determine the usability of the Pixi pediatric mask system in comparison to the patient's usual mask. Usability is defined as comfort, seal, stability, and facial markings. This information will be gathered through clinician and parent questionnaires. Information gathered about the new mask will be compared with information gathered from the patients current mask. The outcome hypothesis is that patients will rate the Pixi paediatric mask significantly better than their current mask, regarding comfort, seal, stability and facial markings.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
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 ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2011)
  • Reduction or 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 ]
    The AHI will be 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 is that the Pixi mask AHI will be equivalent or reduced to the patients usual mask
  • Reduction or equivalence of the amount of mask leak from the new Pixi mask compared with the child's usual mask [ Time Frame: 8 nights ]
    Mask leak from the Pixi mask will be collected and compared with leak data from the patient's usual mask. The outcome hypothesis is that the amount of leak on the new Pixi mask will be reduced or equivalent to the child's usual mask
  • Increase or equivalence in hours of therapy use on the new Pixi mask compared with the child's usual mask [ Time Frame: 8 nights ]
    Therapy compliance (usage hours) on the new Pixi mask will be compared with therapy complaince on the patient's usual mask system. The outcome hypothesis is that usage hours will be increased or equivalent on the new Pixi mask to the child's usual mask
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Usability and Efficacy of a New Pediatric CPAP Mask
Official Title  ICMJE Pediatric Nasal Mask (Pixi) Usability Study
Brief Summary

This study will evaluate a newly developed pediatric mask (known as Pixi) on children aged 2-7 using continuous positive airway pressure (CPAP), or Non-invasive ventilation (NIV) treatment. The participants will undergo a monitored sleep study, followed by a 7 night trial of the Pixi mask in the home environment. During the study usability will be measured through questionnaires filled in by the parent and clinician.

The study hypothesis is that the usability of the mask will be superior to the patient's usual mask.

Detailed Description

This is a prospective, single group, un-blinded study sponsored by ResMed Ltd to investigate the usability of the ResMed Pediatric Nasal Mask (Pixi).

Patients will be recruited from the study site's database. Parents/ guardians of patients who meet the selection criteria and voluntarily agree to participate in the study will be approached by the investigative team to obtain informed consent.

Patients will attend the clinic where baseline information will be collected, including information about the patient's current therapy and data from their last PSG study. Information will be recorded on case report forms (CRF's). Data from the patient's current device will be downloaded during this visit. At this time the Pixi mask will be fitted and adjusted until it is comfortable for the child. The patient's device will be switched to a ResMed VPAP III ST-A with QuickNav if they are not already using one. The VPAP III ST-A with QuickNav will be used in the same mode (CPAP or Bi-level) as the patient's current device.

The participants will undergo a monitored PSG study on the first night of the trial. They will use the Pixi mask and the VPAP III ST-A with QuickNav during this PSG. The initial therapy settings will be based on the child's usual therapy, with any therapy setting modifications made as clinically required during the PSG.

Patients will then use the Pixi mask with the VPAP III ST-A with QuickNav in the home environment for 7 nights. After using the mask in the home environment, the child's legal guardian will rate their satisfaction with the Pixi mask as compared to the child's current mask. The child will also be asked to evaluate the mask if they are able.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea
  • Respiratory Insufficiency
Intervention  ICMJE Device: Prototype mask (known as Pixi)
This is a prototype mask to be used with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) therapy. The mask attaches to the face, covering the nose, and is kept in place with headgear. Therapy is delivered through the mask via a tube which attaches to the CPAP or NIV device.
Other Name: ResMed Pixi paediatric mask
Study Arms  ICMJE Experimental: Prototype mask
Intervention: Device: Prototype mask (known as Pixi)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 23, 2011)
6
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2011)
10
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is between 2-7 years of age
  • Is a current PAP (Bi-level or CPAP) therapy user, defined as being on PAP therapy for at least 1 month prior to study entry
  • Is a current user of a nasal mask
  • Legal guardian can read and comprehend English
  • Legal guardian is willing to give written informed consent

Exclusion Criteria:

  • Recent sinus surgery (within 6 weeks of study entry)
  • Concurrent participation in other clinical trials
  • History of clinically significant epistaxis in the past 6 months
  • Known co-morbidities that, per clinical judgment, would prevent compliance to therapy
  • Other reasons for non-compliance that affect subject's ability to use therapy such as primary claustrophobia
  • Significant cardiac disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01312948
Other Study ID Numbers  ICMJE MA13122010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ResMed
Study Sponsor  ICMJE ResMed
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Margaret-Anne Harris, MBBS, FRACP Lady Cilento Children's Hospital, Brisbane
PRS Account ResMed
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP