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Study of the Usability and Efficacy of a New Pediatric CPAP Mask
Not Recruiting
Trial ID: NCT01312948
Purpose
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.
Official Title
Pediatric Nasal Mask (Pixi) Usability Study
Stanford Investigator(s)
Clete A. Kushida, MD, PhD
Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)
Shannon Sullivan, MD
Clinical Professor, Pediatrics - Pulmonary Medicine Clinical Professor (By courtesy), Psychiatry and Behavioral Sciences - Sleep Medicine
Rafael Pelayo, MD
Clinical Professor, Psychiatry and Behavioral Sciences - Sleep Medicine
Eligibility
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
Intervention(s):
device: Prototype mask (known as Pixi)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Chia-Yu Cardell
6507217576