N/A
Completed N=6
Study of the Usability and Efficacy of a New Pediatric CPAP Mask
Source: ClinicalTrials.gov NCT01312948 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask — 7.17; 5.83 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Usability Ratings of the Pixi Paediatric Mask Compared With the Child's Current Mask |
7.17; 5.83 | — |
| SECONDARY Equivalence of Apnea-hypopnea Index (AHI) on the New Pixi Mask Compared With the Child's Usual Mask |
0.85; 3.25 | — |
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
Data sourced from ClinicalTrials.gov (NCT01312948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.