Study of the Usability and Efficacy of a New Pediatric CPAP Mask

Not Recruiting

Trial ID: NCT01312948


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
Clete A. Kushida, MD, PhD

Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)

Rafael Pelayo, MD
Rafael Pelayo, MD

Clinical Professor, Psychiatry and Behavioral Sciences - Sleep Medicine

Shannon Sullivan, MD
Shannon Sullivan, MD

Clinical Professor, Pediatrics - Pulmonary Medicine Clinical Professor (By courtesy), Psychiatry and Behavioral Sciences - Sleep Medicine


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


device: Prototype mask (known as Pixi)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Chia-Yu Cardell