Clinical trial NCT01312948: Study of the Usability and Efficacy of a New Pediatric CPAP Mask
Official title: Pediatric Nasal Mask (Pixi) Usability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Respiratory Insufficiency
Keywords: Obstructive sleep apnea
OSA
CPAP
CPAP mask
Non-invasive ventilation
NIV
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 6
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask
timeFrame: 8 nights use
Secondary outcomes:
measure: Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask
timeFrame: >4 hours monitored sleep study
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Mater Children's Hospital
state: Queensland
Study officials:
affiliation: Lady Cilento Children's Hospital, Brisbane
name: Margaret-Anne Harris, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References: