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

Trial ID or NCT#

NCT01312948

Status

not recruiting iconNOT 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
Inclusion Criteria:
  1. * 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:
  1. * 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
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Investigator(s)

Clete A. Kushida, MD, PhD
Clete A. Kushida, MD, PhD
Sleep specialist, Neurologist
Professor of Psychiatry and Behavioral Sciences (Sleep Medicine)
Shannon Sullivan, MD
Shannon Sullivan, MD
Sleep specialist
Clinical Professor, Pediatrics - Pulmonary Medicine Clinical Professor (By courtesy), Psychiatry and Behavioral Sciences - Sleep Medicine
Rafael Pelayo, MD
Rafael Pelayo, MD
Sleep specialist
Clinical Professor, Psychiatry and Behavioral Sciences - Sleep Medicine

Contact us to find out if this trial is right for you.

Contact

Chia-Yu Cardell
6507217576

View on ClinicalTrials.gov