At a glance
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Pediatric Nasal Mask (Pixi) Usability Study
In Brief
A clinical study evaluating Prototype mask (known as Pixi) for Obstructive Sleep Apnea and Respiratory Insufficiency. Completed, enrolled 6 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.