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

• 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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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

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.

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.

• Obstructive Sleep Apnea
• Respiratory Insufficiency

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