Study of the Usability and Efficacy of a New Pediatric CPAP Mask
Condition: Obstructive Sleep Apnea; Respiratory Insufficiency
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Insufficiency
Study type: Interventional

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.
    

Intervention name(s): Prototype mask (known as Pixi)
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): ResMed Pixi paediatric mask
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnea; OSA; CPAP; CPAP mask; Non-invasive ventilation; NIV