Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:



  • Device: Prototype mask (known as Pixi)




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

Ages Eligible for Study

2 Years - 7 Years

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Chia-Yu Cardell
Not Recruiting