Is a
Clinical Study attributes
NCT Number
Health Conditions in Trial
Trial Recruitment Size
60
Trial Sponsor
Clinical Trial Start Date
2011
0Primary Completion Date
2011
0Study Completion Date
2011
0Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Device0
Intervention Name
Prototype mask (known as Pixi)0
Interventional Trial Phase
Not Applicable0
Official Name
Pediatric Nasal Mask (Pixi) Usability Study0
Last Updated
June 26, 2017
0Allocation Type
NA0
Intervention Model
Single Group Assignment0
Masking Type
None (Open Label)0
Study 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.
Timeline
No Timeline data yet.
Further Resources
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