Trial ID or NCT#
NCT01312948
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: 2 Years to 7 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Investigator(s)
Clete A. Kushida, MD, PhD
Sleep specialist,
Neurologist
Professor of Psychiatry and Behavioral Sciences at the Stanford University Medical Center
Shannon Sullivan, MD
Sleep specialist
Clinical Professor, Pediatrics - Pulmonary Medicine
Clinical Professor (By courtesy), Psychiatry and Behavioral Sciences - Stanford Center for Sleep Sciences and Medicine
Rafael Pelayo, MD
Sleep specialist
Clinical Professor, Psychiatry and Behavioral Sciences - Stanford Center for Sleep Sciences and Medicine
Contact us to find out if this trial is right for you.
CONTACT
Chia-Yu Cardell
(650) 721-7576
View on ClinicalTrials.gov