Rafael Pelayo
MA 09-09: Pediatric Nasal Mask Usability Study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The objective of this study is to evaluate if a new pediatric mask is equivalent to the subject?s current mask with the Nemo mask. (aka Pixi Mask)
Stanford Recruiting Status:
RecruitingCondition(s):
Lead Sponsor:
ResMed Corp.Collaborator(s):
- ResMed Corp.
Intervention(s):
- Device: NEMO Pediatric Mask (aka Pixi Pediatric Mask)
- Device: VPAP III ST-A
Phase:
Phase 4Eligibility
Health of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Subjects enrolled into the study must meet the following criteria for entry:
? Between 2-7 years of age
? Pediatric patients with diagnosis of sleep apnea (OSA or respiratory insufficiency), per pediatric standards
? Current PAP therapy user. Current defined as on bi-level or CPAP therapy for at least 1 month prior to study entry. Oxygen therapy is allowed.
? Current user of a nasal mask
? Titration PSG study within 6 months of study entry
? Legal guardian can read and comprehend English
? Legal guardian is willing to give written informed consent
Key Exclusion Criteria:
The subject will be excluded from entry if any of the following criteria apply:
? Recent sinus surgery (within 6 weeks of study entry)
? Allergies to mask material
? If on CPAP therapy, a PAP prescription < 4 cm H2O or > 20 cm H2O
? If on bi-level therapy, IPAP/EPAP pressures < 3 cm H2O or > 30 cm H2O
? Current seasonal allergies that interfere with therapy per clinical judgment. (Use of nasal decongestant is not exclusionary)
? Concurrent participation in other clinical trials
? History of clinically significant epistaxis in the past six months
? Known co-morbidities that, per clinician 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
? Chronic respiratory failure
? Status post upper airway surgery of less than 60 days (e.g. tonsillectomy/adenoidectomy)
Ages Eligible for Study:
2 years to 7 yearsGenders Eligible for Study:
Male and FemalePLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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